August 2013 by HMP Communications, LLC

, LLC

™

an HMP Communications Holdings Company

Today’s

Contemporary Approaches to Wound Clinic Management

Focus on:

Negative

Pressure Mechanically Powered NPWT Pairing NPWT & Advanced Wound Therapy

Also in This Issue: Business Briefs Facility in Focus Clinician’s Report August 2013 www.todayswoundclinic.com

SAWC FALL www.sawcfall.com

00_TWC_August_CVR_History.indd 1

8/9/13 4:45 PM

Today’s

Volume 7, Number 6, August 2013 • www.todayswoundclinic.com

Table of Contents • Feature Articles 10

An Historical Perspective on Negative Pressure in Wound Care

Use of Mechanically Powered NPWT: A Clinical Case Study Series

NPWT has undergone a significant maturation since inception. As use of both electrical and mechanical NPWT continues to evolve, what does the wound care provider need to know?

Recent advancements have changed the delivery of negative pressure wound therapy.This article discusses evidence-based benefits among a variety of patients and offers an online exclusive photo slideshow documenting each patient’s care history.

Lee J. Goldstein, MD, FACS, CWS Dot Weir, RN, CWON, CWS

Pairing Advanced Wound Care Therapy With NPWT

Benefits of Negative Pressure Therapy Application in Newborns

As the use of negative pressure increases in the wound clinic, its effects can be accelerated by introducing a complement of advanced therapies.This article explores options for the wound care clinician to consider.

Existence of evidence-based practice for treatment of chronic wounds in premature babies is not extensive. In this rare case study, a nurse discusses closure of a dehisced abdominal wound.

Christina Le, LVN, WCC

TODAY’S WOUND CLINIC® (ISSN 1938-6311), is published by HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. TODAY’S WOUND CLINIC® website, www.todayswoundclinic.com, is registered with all major Internet search engines. Full content is available online to TODAY’S WOUND CLINIC print subscribers. Subscriptions: TODAY’S WOUND CLINIC® annual rates for US subscriptions: $99.00 annual; single copies, $39.00. Single or replacement copies of TODAY’S WOUND CLINIC® are subject to availability. To subscribe to TODAY’S WOUND CLINIC®, call (800) 237-7285, ext. 221, write to TODAY’S WOUND CLINIC®, Circulation Department, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, or visit us online at www.todayswoundclinic.com. Reprints: Bulk professional-quality reprints (minimum quantity 100) of articles may be purchased. Contact the Managing Editor at (610) 560-0500 for information.

01-02_TWC_August_TOC.indd 1

Carol Price, MSN, RN, CWS, DAPWCA

Advertising queries should be addressed to Jeremy Bowden, Publisher, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-4154 Fax: (610) 560-0501. Email: jbowden@hmpcommunications.com Display and classified advertisinG: HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355, Phone: (800) 237-7285 or (610) 560-0500 x259 Corporate Offices HMP Communications, LLC 83 General Warren Boulevard Suite 100 Malvern, PA 19355 Phone: (610) 560-0500 or (800) 237-7285 Fax: (610) 560-0502

, LLC

™

an HMP Communications Holdings Company

8/9/13 4:12 PM

Editorial Staff

Today’s

Clinical Editors and Founding Board Caroline E. Fife, MD, FAAFP, CWS Dot Weir, RN, CWON, CWS

Founding Editorial Board Kathleen Schaum, MS Christopher Morrison, MD Val Sullivan, PT, MS, CWS

Volume 7, Number 6, August 2013 • www.todayswoundclinic.com

Managing Editor Joe Darrah jdarrah@hmpcommunications.com

Table of Contents

Web Editor Samantha Alleman salleman@hmpcommunications.com

Business Staff

Departments 4

Executive Vice President Peter Norris pnorris@hmpcommunications.com VP/Group publisher Jeremy Bowden jbowden@hmpcommunications.com

From the Editor Caroline Fife, MD, FAAFP, CWS

6 Business Briefs Parallel Paths to Medicare Reimbursement: Surgical Dressings & NPWT

Publisher Kristen J. Membrino kmembrino@hmpcommunications.com Sales Associate Brian Hill bhill@hmpcommunications.com

Pumps (Traditional and Disposable) Kathleen D. Schaum, MS

Classified Sales Associate Michael Deleo mdeleo@hmpcommunications.com

24 Industry Insider An Inside Look at Derma Sciences & MTI Inc.

HMP Communications, LLC

Clinician’s Report

PRESIDENT BIll Norton

Educational Aids & Resources

Vice President, Special Projects Jeff Hall

30 Facility in Focus

aking a Multidisciplinary Approach to Care at Denver Wound Healing T Center

34 TWC News Update

Children’s Hospital Launches Pediatric Ulcer Program; FDA Issues Warning Regarding Illegal Diabetes Treatments

Advertiser’s Index

Creative Director Vic Geanopulos vgeanopulos@hmpcommunications.com Art Director Karen Copestakes kcopestakes@hmpcommunications.com Production Manager Elizabeth Vasil evasil@hmpcommunications.com Production/ Circulation Director Kathy Murphy kmurphy@hmpcommunications.com Audience Development Manager Bill Malriat MEETING PLANNER Cynthia Noonan

TWC Online

Find us on Facebook @ www.facebook.com/todayswoundclinic

www.todayswoundclinic.com

MEETING PLANNER Trisha Keppler

www.twcjournal.wordpress.com

HMP Communications Holdings, LLC

Online Exclusive: New Diabetes Reference Tool for Patients

Shire Regenerative Medicine has launched an online resource for diabetes patients. Learn more in our online TWC News Update.

Chairman & Chief Executive Officer Jeff Hennessy Chief Financial Officer Dan Rice Senior Vice President Anthony Mancini

83 General Warren Boulevard, Suite 100, Malvern, PA 19355 Editorial Correspondence should be addressed to Managing Editor, Today’s Wound Clinic®, HMP Communications, 83 General Warren Boulevard, Suite 100, Malvern, PA 19355. Telephone: (800) 237-7285 or (610) 560-0500 /Fax: (610) 560-0502. Editorial policy: TODAY’S WOUND CLINIC® seeks to provide practical, timely insight into clinical and operational issues inherent to the success of an outpatient wound center. Program Directors, Medical Directors, and Clinical Managers (including Nurse Practitioners and other professional wound care providers across multiple disciplines) will benefit from the interactive nature of feature articles and regular departments that address medical and practice management options and perspectives affecting fiscal and, most importantly, patient outcomes of wound clinics. Articles from knowledgeable, experienced practitioners are invited and will be subject to Editorial Board review. , LLC

an HMP Communications Holdings Company

01-02_TWC_August_TOC.indd 2

™

Controller Meredith Cymbor-Jones Director of e-Media and Technology Tim Shaw Senior Director of Marketing Corey Krejcik Sr. Manager, IT Ken Roberts

8/9/13 4:12 PM

fromtheeditor

would give a lot to have a picture of the first “portable” negative pressure wound therapy (NPWT) device used by one of my patients. It was 1977, and a resourceful woman who had experienced an abdominal wound had used bungee cord to attach one of the original NPWT devices that existed (about the size of a carry-on suitcase) to a skateboard.That orange, 50-foot, industrial-strength cord allowed her to ambulate from room to room, her skateboard trailing the NPWT device behind her. Caroline Fife I had been running a wound center for seven years at Co-Editor of TWC that time, and I will never forget the first time I changed an NPWT dressing and saw a field of beautiful granulation tissue — where only days before there had been none. I remember thinking, “This will revolutionize the way we care for patients.” I wasn’t wrong. In this issue of Today’s Wound Clinic, we cover the spectrum of what NPWT means to wound care today. Lee Goldstein, MD, FACS, CWS, provides an historical perspective on negative pressure that will help readers compare mechanical and electronic forms of NPWT. My co-editor and fellow TWC board member Dot Weir, RN, CWON, CWS, discusses evidence-based benefits of the mechanical variety, which represents the next step forward for the innovation of NPWT. The impact of negative pressure utilization is further showcased in the article “Pairing Advanced Wound Care Therapy With NPWT” by Christina Le, LVN, WCC, who details the effects of NPWT when used in conjunction with other therapeutic options to expedite the healing of complex wounds in ways we could not have imagined 20 years ago. Also in this issue, Carol Price, MSN, RN, CWS, DAPWCA, details the delicate use of NPWT to gain closure of a giant omphalocele in newborns, another cutting-edge development in the field.

Strolling Down NPWT Memory Lane I remember the first time we used NPWT in the clinic on a patient living with abdominal compartment syndrome.To cover the viscera, we used an empty plastic IV bag with holes poked through it and applied foam on top. Despite the crudeness of the NPWT dressing, the process was wildly successful and forever changed the management of abdominal compartment syndrome at my institution. For many years, one of the most difficult aspects of NPWT surrounded the paperwork associated with ordering it for our patients. As always, when it comes to financial issues in the wound center, you can’t afford to miss “Business Briefs” by fellow TWC board member Kathleen D. Schaum, MS, who covers reimbursement considerations for surgical dressings as well as traditional and disposable NPWT devices in this issue. It was inevitable that the novel concept of negative pressure would lead to innovative equipment with which to deliver it. Devices have gotten smaller, materials being used at the wound interface have evolved, new ways have been developed to manage tunnels, and novel technology becomes available to control bioburden each day. Originally, NPWT devices actually needed batteries. Eventually, battery life lasted longer; and now it seems electricity can be considered entirely optional for NPWT devices. I wish I could go back in time and show one of today’s tiny NPWT devices to my patient with the skateboard and the 50-foot extension cord, but the future seems just as inspiring. n Caroline Fife, MD, FAAFP, CWS, co-editor of TWC, chief medical officer at Intellicure Inc.

August 2013 Today’s Wound Clinic®

04_TWC_August_Editor.indd 4

Today’s

Editorial Board Founding Editorial Board Members Co-Editor of Today’s Wound Clinic Caroline Fife, MD, FAAFP, CWS Co-Editor of Today’s Wound Clinic Dot Weir, RN, CWON, CWS Christopher A. Morrison, MD, FACHM, FCCWS Valerie Sullivan, PT, MS, CWS Kathleen D. Schaum, MS

Editorial Board Members Andrew J. Applewhite, MD, CWS, UHM Leah Amir, MS, MHA Desmond Bell, DPM, CWS Donna J. Cartwright, MPA, RHA, CCS, RAC, FAHIMA Moira Hayes, MHA, RRT, CHT Cathy Thomas Hess, BSN, RN, CWOCN Harriet Jones, MD, BSN, FAPWCA Robert S. Kirsner, MD, PhD Trisha Markowitz, MSN, MBA-HCM, RN, CWCN, DAPWCA Pamela Scarborough, PT, DPT, MS, CDE, CWS Susie Seaman, NP, MSN, CWOCN Tere Sigler, PT, CWS, CLT-LANA Pamela G. Unger, PT, CWS, FCCWS Randall Wolcott, MD, CWS

, LLC

™

an HMP Communications Holdings Company

83 General Warren Boulevard, Suite 100, Malvern, PA 19355 © 2013, HMP Communications, LLC. All rights reserved. Reproduction in whole or in part prohibited. Opinions expressed by authors, contributors, and advertisers are their own and not necessarily those of HMP Communications, LLC, the editorial staff, or any member of the editorial advisory board. HMP Communications, LLC is not responsible for accuracy of dosages given in articles printed herein. The appearance of advertisements in this journal is not a warranty, endorsement or approval of the products or services advertised or of their effectiveness, quality or safety. HMP Communications, LLC disclaims responsibility for any injury to persons or property resulting from any ideas or products referred to in the articles or advertisements. Content may not be reproduced in any form without written permission. Reprints of articles are available. Contact HMP Communications, LLC for information.HMP Communications, LLC (HMP) is the authoritative source for comprehensive information and education serving healthcare professionals. HMP’s products include peer-reviewed and non-peer-reviewed medical journals, national trade shows and conferences, online programs and customized clinical programs. HMP is wholly owned subsidiary of HMP Communications Holdings LLC. Discover more about HMP’s products and services at www.hmpcommunications.com.

www.todayswoundclinic.com

8/9/13 1:40 PM

businessbriefs

Parallel Paths to Medicare Reimbursement: Surgical Dressings & NPWT Pumps (Traditional and Disposable) Kathleen D. Schaum, MS

Information regarding coding, coverage, and payment is provided as a service to our readers. HMP Communications and the authors do not represent, guarantee, or warranty that the coding, coverage, and payment information is error-free and/or that payment will be received.The responsibility for verifying coding, coverage, and payment information accuracy lies with the reader.

et’s take a walk down memory lane: First, there were gauze surgical dressings.Then, the concept of moist wound healing was introduced. Before long, there were many forms of surgical dressings that created a moist healing environment, such as hydrocolloid, hydrogel, transparent film, etc. As these advanced dressings became widely used, it became obvious that Medicare Part B benefits should cover surgical dressings used by patients in their homes. A group of forward-thinking wound care professionals and manufacturers worked with the Centers for Medicare & Medicaid Services (CMS) to: 1. Create Healthcare Common Procedure Coding System (HCPCS) codes for each of the surgical dressing categories that existed at the time, 2. Establish a Medicare Part B Durable Medical Equipment, Prosthetics/ Orthotics, and Supplies (DMEPOS) Fee Schedule allowable rate for each surgical dressing category, and 3. Write a surgical dressing coverage policy (called a Local Medical Review Policy [LMRP] at the time). As new categories of surgical dressings (eg, alginate, foam, collagen, and 6

TABLE 1. Traditional NPWT HCPCS Codes & 2013 DMEPOS National Average Allowable Rates HCPCS Codes

Description

DMEPOS

A6550

Wound care set, for negative pressure wound therapy electrical pump, includes all supplies and accessories

$25.60

A7000

Canister, disposable, used with suction pump, each

$10.33

E2402

NPWT electrical pump, stationary or portable

$1,601.80

TABLE 2. Traditional NPWT CPT Codes & 2013 National Average Allowable Rates CPT Code

Description

MPFS Office

MPFS Facility

HOPS

97605

NPWT (eg, vacuum-assisted drainage collection), including topical application(s), wound assessment, and instruction(s) for ongoing care, per session, total wound(s) surface area less than or equal to 50 sq cm

$42.53

$26.20

$71.54

97606

Total wound(s) surface area greater than 50 sq cm

$45.25

$29.26

$106.96

compression bandaging) were developed, manufacturers applied to CMS for HCPCS codes for each of the new surgical dressing categories. CMS then established Medicare Part B fee schedule allowable rates for most of the new surgical dressing categories. The Medicare contractors then added coverage language for most of the new surgical dressing categories to their LMRPs. In a few years’ time, manufacturers produced multiple brands in each of the surgical dressing categories. CMS established a website where qualified healthcare pro-

fessionals (QHPs) can verify the correct HCPCS code for each brand of surgical dressing (www.dmepdac.com/dmecsapp/do/search). When the multilayer, high-compression bandage system was developed, several professional societies worked with the American Medical Association (AMA) to create CPT® codes (29581, and later 29582-29584) for this time-consuming work. CMS then established Medicare Part B allowable payment rates for the new CPT codes on the Medicare Physician Fee Schedule (MPFS), on the Hospital Outpatient

August 2013 Today’s Wound Clinic®

www.todayswoundclinic.com

XX-XX_TWC_Aug13_Business.indd 6

8/9/13 2:51 PM

businessbriefs Prospective Payment System (HOPS), and on the Ambulatory Surgery Center payment system. And, you guessed it; Medicare Administrative Contractors (MACs) began writing Local Coverage Determinations (LCDs) about the new compression CPT codes. Because each site of service across the patient’s continuum of care is paid differently, surgical dressings are either: 1. Bundled into the prospective payment system (eg, acute care hospitals, long-term care hospitals, Medicare Part A stay in skilled nursing facilities, etc.) or 2. Paid according to the DMEPOS Fee Schedule (eg, DME suppliers for patient’s use at home, physicians, etc.) for patient’s use at home, or in Medicare Part B-covered stays in skilled nursing. QHPs should not only understand how their site of service is paid, they should also understand how their referral site of service is paid and how the site of service to which they will refer the patient is paid. Coordination of care and use of surgical dressings across the continuum of care are essential. Today, QHPs who specialize in wound care have a variety of surgical dressings from which to choose. Their job is to select the most clinically appropriate surgical dressing that will deliver the best outcomes, the best patient satisfaction, and the lowest total cost of care for the patient, the provider, and the payer.

Look Forward To NPWT Traditional NPWT Pumps Similar to surgical dressings, there was first just one negative pressure wound therapy (NPWT) pump. The manufacturer of that device had the difficult job of introducing NPWT to Medicare; obtaining HCPCS codes for the product, canister, and dressings; obtaining a reasonable DMEPOS Fee Schedule allowable payment rate; obtaining a CPT code to account for the QHPs work of applying the device; working with the DME MACs to write the first LCD for NPWT; and working with the MACs to include positive coverage for the application of NPWT in their LCDs. See Table 1 for a list of HCPCS codes

TABLE 3. LCDs, Articles, and Bulletins Pertinent to Traditional NPWT DME MAC Jurisdiction

DME MAC

LCD/Article ID Number

LCD Title

NHIC Corp.

L11500 A35347

NPWT pumps

National Government Services Inc.

L27025 A47111

NPWT pumps

CGS Administrators LLC

L5008 A35363

NPWT pumps

Noridian Administrative Services

L11489 A35425

NPWT pumps

A/B MAC Jurisdiction

A/B MAC

LCD ID Number

LCD Title/Bulletin Link

CAHABA Government Benefit Administrators LLC

N/A

Coverage based on medical necessity

CGS

5/17/13 Bulletin

www.cgsmedicare.com/kyb/pubs/ news/2013/0513/cope22190.html

First Coast Service Options Inc.

L28991 L29023 L29288 L29398

Non-covered services

6 K

National Government Services Inc.

LL26884 A50612

Outpatient physical and occupational services

National Heritage Insurance Corp.

N/A

Coverage based on medical necessity

Noridian Administrative Services LLC

N/A

Coverage based on medical necessity

Novitas Solutions Inc.

L27547 A47793

Wound care

Novitas Solutions Inc.

L32687

Wound care

1 11

Palmetto GBA

3/1/2013 Bulletin

www.palmettogba.com/palmetto/providers. nsf/DocsCat/Providers~Jurisdiction%201%20 Part%20B~Browse%20by%20Topic~General~ 8LVKTD8412?open&navmenu=%7C%7C

5 8

Wisconsin Physicians Service Insurance Corp.

L28572

Wound care

created for traditional NPWT pumps/ supplies/dressings and the 2013 national average DMEPOS Fee Schedule rates for those codes. These codes and allowable rates apply when a patient obtains the equipment from a DMEPOS provider/supplier and uses the equipment in his/her home. If a home health agency (HHA) is providing care to the patient in the home, the HHA is not required to supply the traditional NPWT pump/ supplies/dressings. The Medicare Part B-covered patient should acquire the NPWT equipment/supplies/dressings from a DMEPOS provider/supplier.

www.todayswoundclinic.com

XX-XX_TWC_Aug13_Business.indd 7

Similar to the “explosion” of surgical dressings on the market after HCPCS codes and DMEPOS Fee Schedule allowable rates became available, numerous brands of NPWT pumps/supplies/dressings with the same/different features are now available in the marketplace. Those interested in ordering a new brand of NPWT pump can find a listing of traditional NPWT pumps/supplies/dressings that CMS verified eligible to use the traditional NPWT HCPCS codes at www. dmepdac.com/dmecsapp/do/search. NOTE: Traditional NPWT pumps/ supplies/dressings were added to the Today’s Wound Clinic® August 2013

8/9/13 2:51 PM

businessbriefs TABLE 4. Disposable NPWT CPT Codes & 2013 National Average Allowable HOPS Rates HCPCS Code

Description

HOPS

MPFS

G0456

NPWT (eg, vacuum-assisted drainage collection), using a mechanically powered device, not DME, including provision of cartridge and dressing(s), topical application(s), wound assessment, and instructions for ongoing care, per session; total wounds(s) surface area less than or equal to 50 sq cm

$209.65

Carrier priced

G0457

$209.65

Carrier priced

Competitive Bidding Program effective July 1. If the patient lives in a competitive bidding area (CBA), the DMEPOS provider/supplier will not be paid the rate listed in Table 1. Instead, the DMEPOS provider/supplier will be paid a single payment rate for that specific CBA. Those competitive bidding rates can be viewed at www.dmecompetitivebid. com. For example: If the patient lives in the Indiana-Chicago Metro competitive bidding area,the single payment rates are: A6550 $24.38 A7000 $7.86 E2402 $800.00 During a recent survey of NPWT manufacturers that asked if they expected competitive bidding to impact payment by the private/commercial payers and by the state Medicaid programs, nearly every manufacturer believed the competitive bidding pricing shifts would influence other payers to adjust their payments to the DMEPOS providers/ suppliers. However, manufacturers are concerned that many DMEPOS providers/suppliers may not financially survive if this occurs because the competitive bidding rates are very low compared to the traditional fee-for-service allowable rates. See Table 2 for an overview of the 2013 national average MPFS and HOPS allowable payment rates. If the NPWT pump/dressings are applied to the patient’s wound in a physician’s office, Column 3 in Table 2 provides the national average Medicare allowable payment rate. Column 4 in Table 2 provides the national average Medicare allowable payment rate for physicians who personally apply the pump/supplies/ dressings to patients in facilities such as 8

hospital-based outpatient wound care departments (HOPDs). CAUTION: If a physician orders NPWT to be applied in an HOPD but does not personally apply the pump/supplies/dressings, the physician should not report these codes on his/her claim. If the NPWT pump/ supplies/dressings are applied during a patient’s encounter at the HOPD, Column 5 in Table 2 provides the HOPS national average Medicare allowable payment rate. When NPWT pump/supplies/dressings are applied in an acute care hospital, a long-term care hospital, and a skilled nursing facility during a Medicare PartA covered stay, the facility is responsible for purchasing/renting the equipment/ supplies/dressings out of their respective Medicare payments: medical severity diagnosis related group payment, long-term care diagnosis related group payment, and resource utilization group payment. See Table 3 for the links to the pertinent DME MACs’ LCDs and MACs’ LCDs effective July 1. As we have often discussed in “Business Briefs,” the existence of a HCPCS and/or CPT code and the existence of a published payment rate does not guarantee coverage. If the Medicare contractor does not publish an LCD, the contractor evaluates each claim based on medical necessity. If the Medicare contractor publishes an LCD, then the contractor evaluates each claim based upon the LCD guidelines. As you can see from the first four lines of Table 3, all four DME MACs have published an LCD regarding traditional NPWT. Therefore, QHPs who order NPWT for patients at home should pay particular attention to the LCD requirements for

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug13_Business.indd 8

orders, medical-necessity guidelines, utilization guidelines, and documentation guidelines.The QHP must provide all information required by the LCD to the DMEPOS provider/supplier who will be providing the pump/supplies/dressings. As you can see from the remainder of Table 3, some Medicare A/B MACs have published an LCD that pertains to the application of traditional NPWT pumps/supplies/dressings. QHPs, therapists, and HOPDs should pay particular attention to these LCDs that typically provide guidance regarding orders, medical necessity, utilization, and documentation. Disposable NPWT Pumps To satisfy patients’ requests to reduce the size of NPWT pumps,manufacturers have developed numerous small, disposable devices. QHPs should review the nuances of each brand and select the appropriate device for each patient. QHPs should not expect disposable pumps to be reimbursed in the same manner as traditional pumps because they are innovative, they fulfill different patient needs than traditional pumps, and they are not “DME.”Additionally, the disposable devices have entered the market at a time when wound care professionals are being challenged to manage patients across the continuum of care, rather than in a single site of service. In these cases, rather than focusing on cost versus reimbursement, wound care professionals may find that these products can fit perfectly into protocols that are focused on quality of care, patient satisfaction, and lowest total cost of care across the continuum. In fact, some patients may begin with traditional pumps and tranwww.todayswoundclinic.com

8/9/13 2:51 PM

businessbriefs

sition to disposable pumps. Or, some patients may not need traditional pumps and may begin with disposable devices. For those QHPs and sites of care that are still focused on how products are reimbursed in a single site of service, let’s take a quick look at the early stages of coding, payment, and coverage for the disposable pumps: If QHPs want this reimbursement to change, they must take an active role in educating the payers about the value of disposable technology. Remember: We would not have the LCDs for surgical dressings if wound care professionals had not rolled up their sleeves and helped the manufacturers educate the payers about the new dressings, the need for HCPCS/CPT codes, the need for published allowable payment rates, and the need for coverage even if the products are not “DME.” As of July 15, CMS has created two temporary HCPCS codes (G0456 and G0457) that have published allowable rates on the HOPS Fee Schedule and that are “carrier priced” when physicians perform the work (see Table 4). Like many new codes, the allowable rates may/may not be adequate to cover the cost of the devices/supplies. In these instances, QHPs should take the time to educate the payers about the actual invoice price of the products. Remember how providers influenced the Medicare allowables for surgical dressings? Like surgical dressings, disposable NPWT devices/supplies/ dressings are included in the Medicare payments to hospitals, long-term care hospitals, and skilled nursing facilities during a patient’s Medicare Part A-covered stay. In addition, HHAs must purchase disposable NPWT devices/supplies/dressings for patients receiving Medicare Part A-covered home health services. HOPDs and physicians may receive payment for the application of disposable NPWT devices/supplies/dressings via HCPCS codes G0456-G0457, if the service is covered by their MAC. Also, as of July 15, AMA has not created a CPT code for the application of disposable NPWT pumps/ supplies/dressings. When you review MAC LCDs, articles, and bulletins listed in Table 3, you will find a “mixed bag” of Medicare coverage: Some have not written an LCD and cover based on medical necessity; some consider the products non-covered; some have provided coverage guidelines through LCDs or bulletins. QHPs should read these documents carefully and implement the guidelines into their practices. QHPs should also educate their respective payers when the payers make coverage determinations that do not necessarily align with achieving optimum outcomes, patient satisfaction, and lowest total cost of care. n Kathleen D.Schaum is president and founder of Kathleen D.Schaum & Associates Inc., LakeWorth, FL. She can be reached for questions and consultations at 561-964-2470 or kathleendschaum@bellsouth.net. Acknowledgements: The author and TWC would like to thank the manufacturers that participated in a survey used for this article: Devon Medical Products, Equinox Medical LLC, Innovative Therapies Inc., Medela Inc., and Spiracur Inc. www.todayswoundclinic.com

XX-XX_TWC_Aug13_Business.indd 9

Today’s Wound Clinic® August 2013

8/9/13 2:51 PM

An Historical Perspective on

Negative Pressure in Wound

Care

Use of both electrical and mechanical NPWT continues to evolve. What does the wound care provider need to know? Lee J. Goldstein, MD, FACS, CWS

odern wound care has increased substantially, both in volume and complexity. To help address the spike in demand, there has been a concomitant advancement in both products and devices that are aimed at improving wound treatment. Negative pressure wound therapy (NPWT) has enjoyed a significant increase in use, and the devices employed have become more refined over time. There has been substantial debate over the efficacy of these devices, with publications often finding the data inconclusive.1 Recent meta-analyses, however, have shown NPWT to be an effective treatment for chronic wounds.1 In addition to its impact on wound healing, control of exudate, ease of wound care, maintenance of appropriate wound moisture, and device portability have all added to the desirability of NPWT in the wound clinic. As wound care itself continues to evolve as a science, new devices and dressings are arriving that offer additional benefits to patient care. Mechanically powered NPWT represents a fresh take on NPWT, with its own unique advantages. This article reflects on the progress we have seen in NPWT in general and compares the usage of electrical and mechanical NPWT, which should be considered as yet another tool within the wound care practitioner’s armamentarium.

NPWT: A Continuous Improvement

NPWT has undergone a significant maturation since inception. Surgically closed suction drains represent the earliest forms of NPWT.These drains close “dead space” and remove exudate, but are crude approaches to negative pressure. As experience increased, there were makeshift attempts at developing NPWT by using occlusive dressings and wall suction that was often delivered by surgical drains (Figure 1). This marked an improvement on simple, closed-suction drains by offering wound coverage, moisture control, exudate management, and “24-hour wound care” versus intermittent dressing changes. 10 August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_NPWT_History.indd 10

www.todayswoundclinic.com

8/9/13 1:44 PM

negativepressure As formal negative pressure devices came into the wound care market, treatment enjoyed an upgrade with measurable, constant pressure and improved dressings. The mechanism of action of these devices relies on simple physics. There is no true “negative pressure,” as everything around us exerts pressure — even atmospheric air. Atmospheric air is approximately 15 psi at sea level. Increases in altitude decrease this pressure (as there is less atmospheric air contributing to the pressure) and submersion in depths of water increases the pressure (due to the added pressure of the overlying water). Thus, there is only “relatively” negative pressure in that the pressure lower than atmospheric pressure is referred to as “negative.” Successful NPWT manages to provide adequate negative pressure in the setting of a changing wound environment.

Figure 1: Early attempts at NPWT using surgical dressings and wall suction.

Mechanical Vs. Electrical NPWT

“Pressure” is defined as the density of air (or matter) in a given space. Powered NPWT removes air from the wound, creating a “negative” pressure environment (Figure 2). Alternatively, the space can be increased while maintaining the same amount of air, therefore decreasing the density of the air and the pressure in the space (Figure 3). This is the mechanism of action of mechanically powered NPWT, which utilizes a constant-force spring that applies a continuous force to the wound space and maintains a constant pressure. This allows the device to adjust to exudates and air leaks as needed to maintain an appropriate level of negative pressure (Figure 4). Both electrically powered negative pressure and mechanically powered negative pressure devices reduce air density and apply constant pressure. Mechanically powered NPWT devices, however, offer advantages such as smaller size of equipment, portability, shelf storage/availability, and no need for an electrical charge. Electrically powered NPWT may be better suited for larger wounds or those with excessive exudate, as mechanical products are constrained by limited canister size. One multicenter, randomized controlled trial directly compared these

Figure 2: Powered NPWT devices create a “negative” pressure environment by removing air from a fixed space.

Figure 3: Mechanically powered NPWT devices create a “negative” pressure environment by enlarging the volume of space the air occupies.

two approaches to NPWT among 132 patients living with diabetic wounds and venous ulcers. According to the findings, no difference in healing rates occurred when considering the use of mechanically powered versus electrically powered NPWT.2 Additionally, both forms of NPWT have been introduced for closed-incision use. Both also aid in wound-tension relief, control of exudate, and maintenance of a sterile environment. Wound care of the closed surgical incision with devices such as these will hopefully prevent future need for chronic wound care. n

www.todayswoundclinic.com

XX-XX_TWC_Aug_NPWT_History.indd 11

Figure 4: Mechanically powered NPWT devices adapt to a changing wound environment by applying a constant force (red arrow) over a fixed area (green disk). This results in a consistent negative pressure application to the wound (blue arrow).

Lee J. Goldstein is assistant professor of surgery in the division of vascular surgery at University of Miami Miller School of Medicine’s DeWitt Daughtry Family Department of Surgery. He may be reached at lgoldstein@med.miami.edu. References 1. Suissa D, Danino A, Nikolis A. Negativepressure therapy versus standard wound care: A meta-analysis of randomized trials. Plast Reconstr Surg. 2011;128(5):498e–503e. 2. Armstrong DG, Marston WA, Reyzelman AM, Kirsner RS. Comparative effectiveness of mechanically and electrically powered negative pressure wound therapy devices: A multicenter randomized controlled trial. Wound Repair Regen. 2012;20(3):332–41. Today’s Wound Clinic® August 2013

8/9/13 1:44 PM

Use of Mechanically Powered NPWT: A Clinical Case Study Series Recent advancements have changed the delivery of negative pressure wound therapy. This article discusses evidence-based benefits among a variety of patients. Dot Weir, RN, CWON, CWS

he goal of care with any of our patients in the outpatient wound clinic is to get the wound healed as rapidly as we possibly can. This means attempting to make an early, accurate diagnosis and, with few exceptions, simultaneously concentrating on improving the wound bed to prepare it for healing as that diagnosis is being made. Preparing a wound bed for healing includes debridement, reducing bioburden and edema, and managing moisture in order to promote a granular wound bed. This is accomplished by a careful and detailed wound assessment in order to identify the barriers to healing and the needs of the wound. Wound specifics such as location, size, amount of exudate, current tissue type, and bacterial burden drive wound care clinicians toward a treatment decision, along with the support needs required (compression, offloading, nursing care). The result of this assessment allows us to set goals based on patients’ needs. Wounds are dynamic and change frequently, so our assessments must be performed at routine intervals in order to adjust the treatment plan as the wound bed changes and evolves. One tool that we have to enhance the process of wound bed preparation as well as the promotion of granulation tissue is negative pressure wound ther-

TABLE 1. RCT Exit Survey Demonstrates Significant Improvement in Patient Quality of Life Percentage of patients who…

Mechanical System

Powered System

… said their NPWT device was “comfortable to wear.”

74%

31%

… said their NPWT did not interfere with their daily activities.

85%

54%

… said their NPWT was “rarely” noticed in social situations.

81%

35%

… said their NPWT did NOT disrupt their sleep.

79%

60%

apy (NPWT). Many years of use have allowed wound clinicians to easily identify those patients who would benefit from this therapy, and we have become exceptionally skilled at the creative “art” of application for this therapy. NPWT enables us to remove deleterious wound exudate and reduce periwound edema, thereby improving perfusion and promoting granulation tissue. The oftenpredictable wound bed changes set the stage for either complete healing or preparation for other treatments such as cell-therapy products or skin grafting.

NPWT Delivery

In recent years, there have been advancements made in the delivery of NPWT, such as using smaller devices that need no electrical power source. There

12 August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_Mechanical.indd 12

are still some methods available that are battery operated (with exudate transferred to a foam dressing or a replaceable canister) and that have audible alarms should the seal be lost. There is also one that uses mechanical power generated by a constant-force spring mechanism that delivers the same negative pressure to the wound surface as powered systems, but uses a cartridge that is easily hidden away in pockets or strapped to the patient’s arm or leg. This small and silent device can have a dramatic impact on the quality of life for those who would benefit from NPWT, yet who have the desire to work, engage in social activities, and/ or require safe ambulation that enables active participation in therapy. For those living with lower extremity wounds on the, the risk of falls is reduced by elimiwww.todayswoundclinic.com

8/9/13 1:42 PM

negativepressure nating the need for tubing that might extend from the foot or leg to a suction unit carried on the shoulder. With no audible alarms, visual cues are instead provided should a seal or suction be lost, again making use in social situations more acceptable, as well as eliminating disruption during sleep. Additionally, there is now reimbursement for use of these devices in the outpatient clinic and physician offices, both from the Centers for Medicare & Medicaid Services (CMS) and, in most cases, there has been excellent acceptance and reimbursement from managed care and private insurers. These mechanically powered negative pressure wound therapy (MPNPWT) options are also unique in that they use a thin hydrocolloid dressing used over either foam or gauze that is “kind” to skin, easy to seal, and compatible with the additional supplies often used in hard-to-seal areas such as pectin rings, pectin paste, and hydrocolloid dressings. Use of these devices will not replace our need for larger powered units. For wounds with greater amounts of exudate, the larger units are still required. But as wounds become smaller and less exudative, the transition to the smaller units is a natural progression. For wounds that are thought to only require NPWT for a shorter period of time, the off-theshelf convenience for beginning and ending therapy has also been impactful. There is also considerable cost savings because charges are generated for just as long as the therapy is required, eliminating the need for a monthly rental for short-term usage when used for wound bed preparation or other brief therapy durations such as bolstering skin grafts. The impact on patient satisfaction has been demonstrated in a randomized controlled trial comparing MPNPWT to a powered system. (See Table 1 on page 12.) This improvement in quality of life has been replicated in clinical usage of MPNPWT conducted by the author. (See box at right.) The first patient experienced a deep wound to his lateral calf that failed to respond to powered NPWT. When queried if he was using the therapy as required, he ex-

plained that he “worked two jobs, one at a theme park and another at a convenience store.” He couldn’t have the device exposed to the public at either job, so he only connected for the few hours he was home to sleep. MPNPWT was initiated and the wound was closed in four weeks. This set the stage for the realization that the utility of MPNPWT

Dot Weir is co-editor and member of the Today’s Wound Clinic editorial board.

ONLINE EXCLUSIVE: MECHANICAL USE OF NPWT – PHOTO SLIDESHOWS TWC takes you through each patient’s care trajectory in an exclusive series of photos at www.todayswoundclinic.com.

CASE NO. 1: RADIATION INJURY

Early use of MPNPWT for patients living with challenging wounds proved beneficial with a recent 76-year-old female with wounds/issues related to radiation injury to the site of a radical mastectomy 28 years ago. The patient developed an abscess in her right axilla that was necrotic and draining, and she had no use of her right arm secondary to destruction of her shoulder joint from the radiation. In order to get the exudate under control and the wound cleaner, the decision was made to use MPNPWT, utilizing the gauze interface that was available. The device was used for a few months until the wound became manageable for her with only use of her left arm to change the dressings. (See “Radiation Patient” in the online version of this article.)

CASE NO. 2: RECURRENT VENOUS ULCERS

This 72-year-old male had been in the original clinical trial for the MPNPWT device. He had a long history of recurrent venous leg ulcers and a cerebrovascular accident at the age of 43 that left him ambulating with a walker and an unsteady gait. After two weeks of standard care and compression wraps, he requested to resume the device because he had had experienced positive outcomes during the trial. After 20 days of therapy, the wound improved and a bi-layer cell therapy was applied. (See “Venous Patient” in the online version of this article.)

CASE NO. 3: NECROTIZING INFECTION

A 21-year-old female living with necrotizing infection following a cosmetic procedure. Wound was debrided and NPWT was ordered, but patient was uninsured and did not qualify for charity NPWT device. She had small children at home and did not qualify for home care. In order to facilitate discharge from hospital, MPNPWT was utilized. Rapid reduction in wound size and exudate in four weeks enabled complete closure to be accomplished with dressings and reduced potential for contamination in her home setting. (See “Necrotizing Infection” in the online version of this article.)

CASE NO. 4: OSTEOMYELITIS ULCER

Male, 50, with postoperative wound secondary to a fifth-ray amputation for an infected foot ulcer with osteomyelitis. Patient was enrolled in the MPNPWT trial and randomized to the study device. Of note, in the clinical trial complete closure was the endpoint, which is not typically how NPWT is used. Tubing was trimmed shorter and cartridge was strapped to his lower leg. (See “Osteomyelitis Ulcer” in the online version of this article.)

CASE NO. 5: BURN PATIENT

Development of a deep, full-thickness burn in a 70-year-old male with extravasation of intravenous fluids to his right (dominant) hand, to which he applied a chemical heat pack. (See “Burn Patient” in the online version of this article.)

14 August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_Mechanical.indd 14

in the working population is evident. What follows is a summary of case study results using MPNPWT. For extensive photos relating to each patient’s care, refer to the online version of this article at www.todayswoundclinic.com. n

www.todayswoundclinic.com

8/12/13 10:44 AM

Pairing

Advanced Wound Care Therapy With NPWT As the use of negative pressure increases in the wound clinic, its effects can be accelerated by introducing a complement of advanced therapies. Christina Le, LVN, WCC

18 August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_NPWT_AdvWndCare.indd 18

www.todayswoundclinic.com

8/9/13 1:46 PM

negativepressure

ny wound care provider is going to continuously seek new approaches to wound therapies that improve patient healing times. Negative pressure wound therapy (NPWT) has grown to be an important adjunctive therapy in any wound care setting due to its ability to promote wound healing in different types of wounds with granulation tissue formation. NPWT also has shown improvement in decreasing local edema and has proven to help reduce bacterial levels in tissue. The use of NPWT is further bolstered when it’s coupled with certain advanced wound care dressings that, when used together, have further quickened healing rates and improved the patient care experience.This article discusses the efficacy of these treatment modalities and offers product recommendations for the wound care clinic.

Addressing Pain & Maceration

One of the most common complaints that wound care nurses hear when it comes to application of NPWT is the pain that occurs when trying to remove foam dressings that can adhere firmly to granulation tissue. The use of a nonadherent wound contact layer such as ADAPTIC TOUCH™ (Systagenix) that features a silicone coating to the contact layer allows comfort and ease of removing the foam dressing from the wound bed.1 Another option is to ensure that lidocaine (liquid) is available to soak through the foam dressing before trying to remove the dressing. This not only loosens the foam dressing from the wound bed but decreases the level of pain felt while doing so. Another common complication that can arise with NPWT is when the edges of a wound become macerated. This can be minimized through the application of a skin preparation to the surrounding periwound skin before providing the initial drape. This skin prep forms a film that prepares the skin for the adhesiveness of the drape, allowing skin to adhere better by removing oils in the skin while reducing the possibility of abrasion when removing the drape. Most brands of skin prep now offer an alcohol-free wipe that doesn’t cause a stinging sensation. However, clinicians

should ensure that the foam dressing is never overlapping wound margins and that it’s cut to fit the wound appropriately in order to minimize maceration. If the skin has already become macerated, a solution to prevent further breakdown of the surrounding periwound is to apply a calcium alginate along the border of the wound bed. If the skin prep is applied first, apply the alginate along the edge of the wound margins followed by the draping, which should be allowed to extend the length of the alginate for a guaranteed secure seal and prevention of further moisture and skin deterioration. Regarding the seal, there are instances when the NPWT can “spring a leak.” This can happen quite frequently, especially when trying to apply the NPWT around an ankle or the toe(s). To lessen the risk of a leak, apply compression to the limb needing NPWT. The Setopress® high-compression bandage (Mölnlycke Health Care) can help stabilize NPWT and provide enough pressure to prevent possible leaks, especially if the patient is able to ambulate. When applying NPWT near the dorsal foot/toes, also use podiatry felt or foam between the toes to give a better seal and to assist with any drainage that can accumulate in this area and cause maceration.

Handling Wound Complexity

Those wounds that are more complex with deep tunneling can benefit from the use of PROMOGRAN® or PROMOGRAN PRISMA (Systagenix), collagen dressings that contain oxidized regenerated cellulose (ORC).2 The difference between the two products is that Prisma has a 1% silver ORC added into its suspension before the freeze-drying stage. Both dressings have shown to reduce matrix metalloproteinase (MMP) activity in chronic wound fluid.3 MMPs are from an enzyme family that is very important in wound healing and are normally produced in low levels of cell migration. But when they develop in high concentrations, they can destroy extracellular matrix proteins and allow no support for cell adhesion. When ap-

20 August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_NPWT_AdvWndCare.indd 20

plying this collagen dressing to the base of the wound bed before applying the foam dressing, time of tissue growth can be accelerated by several weeks. Although the white foam for tunneling or undermining wounds is recommended, its density can allow for less suction and can be more difficult to get into those areas. Collagen is applied more easily and has shown to fill tunneling and undermining areas quickly while allowing needed suction to that area. One technique for tunneling wounds is to roll Promogran or Prisma into a cylinder and tuck it in gently, then applying a foam dressing on top. For undermining wounds, tuck the collagen into the specific areas and add several layers if needed, then apply the foam dressing to the remainder of the wound bed. The biological skin substitute Dermagraft® (Shire Regenerative Medicine) has also shown great results when applied with NPWT in wounds that are healing. The physician should prepare the skin substitute as directed by the manufacturer. Once applied to the wound, the skin substitute can be fastened with Steri-Strips™ (3M), and ADAPTIC TOUCH can be applied on top of the graft to guarantee fewer disturbances to the graft site and protect the graft from being pulled into the foam dressing. Dermagraft works well with NPWT because it helps maintain the exudate level of the wound, which allows the skin substitute to adhere and be better absorbed into the wound bed. When these therapies are used together, a decrease in the amount of time the patient required NPWT has been noted. n Christina Le is lead clinical nurse with Wound Care Advantage, Sierra Madre, CA. References 1. International case studies using Adaptic Touch non-adhering silicone dressing: Case Studies. Accessed online at www.systagenix.com/ourproducts/lets-comfort/adaptic-touch-42. 2. Cullen B, Ivins N. Promogran & Promogran Prisma made easy. Wounds Int. 2010;1(3). 3. Cullen B, Smith R, McCulloch E, et al. Mechanism of action of Promogran, a protease modulating matrix, for treatment of diabetic foot ulcers. Wound Repair Regen. 2002; 10(1):16-25. www.todayswoundclinic.com

8/9/13 1:46 PM

Benefits of Negative Pressure Therapy Application in

Newborns Existence of evidence-based practice for treatment of chronic wounds in premature babies is not extensive. In this case study, a nurse discusses closure of a dehisced abdominal wound. Carol Price, MSN, RN, CWS, DAPWCA

he literature and support for use of negative pressure wound therapy (NPWT) in neonates and infants living with dehisced abdominal wounds is sparse. NPWT has been used on infants for open wounds related to surgical complications, but the actual process for application and the amount of negative pressure suction to use is limited to a few anecdotal/case review articles in the literature. As the inpatient wound resource nurse in a large community teaching hospital, this author has been exposed to a number of full-term neonates and preterm patients who may have benefited from the use of NPWT. This article discusses the different forms of abdominal wall defects seen in neonates and the role of NPWT in one severe omphalocele in a patient cared for within the last 3 years.

Variations in Neonatal Birth Defects

Abdominal wall defects in neonates occur in three forms: omphalocele, gastroschisis, and hernia of the umbilical cord. Omphalocele is a defect in the anterior abdominal wall when the intestines, and sometimes the liver, are contained in the omphalocele sac with the umbilical cord attached at the omphalocele sac. Isolated omphalocele occur in approximately 1 in 5,000 live births. A “giant” omphalocele contains at least 75% of the liver, intestines, and may include other intra-abdominal organs such as the spleen and stomach.1

Dermagraft

Human Fibroblast-Derived Dermal Substitute Essential Prescribing Information

application of Dermagraft, subsequent sharp debridement of the ulcer should continue as necessary. Additional wound preparation should minimize disruption or removal of previously implanted Dermagraft. (13) Patient Counseling Information: After implantation of Dermagraft, patients should be instructed not to disturb the ulcer site for approximately 72 hours (three days). After this time period, the patient, or caregiver, should perform the first dressing change. The frequency of additional dressing changes should be determined by the treating physician. Patients should be given detailed instructions on proper wound care so they can manage dressing changes between visits. Compliance with off weight-bearing instructions should be emphasized. Patients should be advised that they are expected to return for follow-up treatments on a routine basis, until the ulcer heals or until they are discharged from treatment. Patients should be instructed to contact their physician, if at any time they experience pain or discomfort at the ulcer site or if they notice redness, swelling, or discharge around/from the ulcer. (8) How Supplied: Dermagraft is supplied frozen in a clear bag containing one piece of approximately 2 in x 3 in (5 cm x 7.5 cm) for a single-use application. The clear bag is enclosed in a foil pouch and labeled unit carton. Caution: Dermagraft is limited to single-use application. Do not reuse, refreeze, or sterilize the product or its container. Dermagraft is manufactured using sterile components and is grown under aseptic conditions. Prior to release for use, each lot of Dermagraft must pass USP Sterility (14-day), endotoxin, and mycoplasma tests. In addition, each lot meets release specifications for collagen content, DNA, and cell viability.

Numbers in parentheses ( ) refer to sections in the Directions for Use of the product labeling. Device Description: Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. (1) Intended Use/Indications: Dermagraft is indicated for use in the treatment of full-thickness diabetic foot ulcers greater than six weeks duration which extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure. Dermagraft should be used in conjunction with standard wound care regimens and in patients that have adequate blood supply to the involved foot. (2) Contraindications: • Dermagraft is contraindicated for use in ulcers that have signs of clinical infection or in ulcers with sinus tracts. • Dermagraft is contraindicated in patients with known hypersensitivity to bovine products, as it may contain trace amounts of bovine proteins from the manufacturing medium and storage solution. (3) Warnings: None (4) Precautions: Caution: The product must remain frozen at -75°C ± 10°C continuously until ready for use. Caution: Do not use any topical agents, cytotoxic cleansing solutions, or medications (e.g., lotions, Dermagraft is packaged with a saline-based cryoprotectant. This solution is supplemented with 10% DMSO ointments, creams, or gels) on an ulcer being treated with Dermagraft as such preparations may cause (Dimethylsulfoxide) and bovine serum to facilitate long-term frozen storage of the product. Refer to the reduced viability of Dermagraft. step-wise thawing and rinsing procedures to ensure delivery of a metabolically active product to the wound Caution: Do not reuse, refreeze, or sterilize the product or its container. bed. (9) Caution: Do not use the product if there is evidence of container damage or if the date and time stamped Customer Assistance: For product orders, technical support, product questions, reimbursement on the shipping box has expired. information, or to report any adverse reactions or complications, please call the following number which is Caution: Dermagraft is packaged with a saline-based cryoprotectant that contains 10% DMSO operative 24 hours a day: (Dimethylsulfoxide) and bovine serum. Skin and eye contact with this packaging solution should be avoided. Shire Regenerative Medicine Customer Service Caution: Dermagraft has not been studied in patients receiving greater than 8 device applications. (877) DERMAGRAFT or (877) 337-6247 Caution: Dermagraft has not been studied in patients with wounds that extend into the tendon, muscle, Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician (or properly joint capsule, or bone. Dermagraft has not been studied in children under the age of 18 years, in licensed practitioner). pregnant women, in patients with ulcers over a Charcot deformity of the mid-foot, or in patients receiving Shire Regenerative Medicine, Inc. corticosteroids or immunosuppressive or cytotoxic agents. US PAT Nos. Caution: To ensure the delivery of metabolically active, living cells to the patient’s wound, do not hold 4,963,489; 5,266,480; 5,443,950 Dermagraft at room temperature for more than 30 minutes. After 30 minutes, the product should be ©2012 Shire Regenerative Medicine, Inc. discarded and a new piece thawed and prepared consistent with Preparation for Use instructions. All Rights Reserved Caution: The persistence of Dermagraft in the wound and the safety of this device in diabetic foot ulcer DERMAGRAFT is a registered trademark of Shire Regenerative Medicine, Inc. patients beyond six months has not been evaluated. Testing has not revealed a tumorigenic potential for cells contained in the device. However, the long-term response to these cells is unknown. Caution: Always thaw and rinse product according to the Preparation for Use instructions to ensure the delivery of metabolically active, living cells to the patient’s wound. Caution: Do not use Dermagraft after the expiration date indicated on the labeled unit carton. (5) Adverse Events: In clinical studies conducted to date, the overall incidence of reported adverse events was approximately the same for patients who received Dermagraft compared to those who received the Control treatment. (6) 11095 Torreyana Road Maintaining Device Effectiveness: Dermagraft must be stored®continuously at -75°C ± 10°C. 22 August 2013 Today’s Wound Clinic www.todayswoundclinic.com San Diego, CA 92121-1104 Dermagraft must be thawed and rinsed according to the Preparation for Use instructions. After the initial

XX-XX_TWC_Aug_Preemie.indd 22

8/9/13 3:43 PM

negativepressure Generally, the defect is closed by conducting a primary closure or a multistep staged closure. Dehisced abdominal wounds in neonates are often treated by the surgical team with twice-per-day moistened saline gauze.

Giant Omphalocele Preemie Case

ns ents if

sts.

In 2010, I was asked to evaluate an infant who had been born at 37 weeks with a giant omphalocele that had begun to separate at the suture line 21 days after surgical repair due to tension on the surgical incision. Initially placed in an advanced wound dressing that was needed over a relatively small area of separation (1.7 cm x 1 cm x 0.1 cm), the wound measured 4.5 cm x 4 cm x 0.2 cm 24 hours later. The pediatric surgeon was consulted at that time to discuss the possible use of NPWT. In this particular case, the surgeon had ordered NPWT as a means of closure, which increases the rate of healing, decreases bacterial burden, and decreases dressing changes from twice daily with the traditional moistened gauze dressing to three times per week with the NPWT dressing. After an advanced wound care product with silver gel was used for two days, NPWT was administered with the wound continuing to dehisce due to the continued tension on the suture line. Application of the NPWT dressing was completed in the usual manner, with use of drape to protect the periwound skin and the skin under the bridge for the T.R.A.C. Pad (KCI). Due to the lack of fascial covering the abdominal cavity, it was decided to bridge the T.R.A.C. Pad away from the top of the wound. This was possible in large part because of the infant’s size and weight. Additionally, there was enough surface area on the abdomen provided to place the T.R.A.C. Pad away from the wound bed. After prepping with the drape, coarse petrolatum gauze was used to cover the wound, with white foam placed over the wound and a black foam for the bridge — all of which was covered with NPWT drape. The white foam was used to decrease adherence to the wound base and to

After three days of NPWT, wound had decreased by 1 cm in both length and width.

With little output from the wound with the white sponge and the 25 mm Hg suction, dressing was changed to coarse petroleum and black foam.

provide hydrophilic foam with decreased suction to the wound bed. The NPWT suction was initially set at 25 mm Hg continuous. After five days of NPWT as described above, the dressing was changed to coarse petrolatum gauze in order to provide protection to the wound while the black foam dressing maintained a bridged area

www.todayswoundclinic.com

XX-XX_TWC_Aug_Preemie.indd 23

for the T.R.A.C. Pad. Also, at this time the suction was increased to 50 mm Hg continuous. This dressing was maintained for two weeks with continued, slow-andsteady decrease in the size of the wound and increase in granulation tissue. After one month of NPWT, the wound had decreased from 4 cm x 4.5 cm to 1.5 cm x 1.2 cm. A collagen product was then contiuned on page 29 Today’s Wound Clinic® August 2013

8/9/13 3:43 PM

industryinsider An Inside Look at Derma Sciences

or this month’s feature, Today’s Wound Clinic spoke with Ed Quilty, CEO.

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare? Ed Quilty Ed Quilty, (EQ): I have been CEO involved in wound care since 1992. I was CEO of MedChem Products, a public company on the New York Stock Exchange that was acquired by C.R. Bard at the end of 1995. I joined the board of Derma Sciences in 1996 and became full-time CEO in June 2000. TWC: What’s your day-to-day role? EQ: As chairman and CEO of Derma, I am responsible for all aspects of our business. We have grown tremendously over the last 12 years.Today, we focus on three segments of the wound care business:pharmaceutical development, advance wound care (AWC), and traditional wound care.

TWC: What do you find most rewarding about providing for your industry? EQ: The biggest reward is hearing the stories from patients and caregivers about how our products have improved and, in some cases, even saved the lives of patients with chronic, nonhealing wounds. TWC: How would you describe the overall mission of your company? EQ: We are a company whose mission is to develop and deliver solutions for AWC management. TWC: What’s new with your company in 2013? 24

EQ: The biggest news this year is the commencement of both our pivotal phase III studies on DSC127 (a first-line treatment for the healing of diabetic foot ulcers that, if unresolved, could lead to amputation with a mortality rate of 45% within five years) as well as the safety/ chronic use study. More than 85 clinical sites will treat almost 1,300 patients to complete these studies. It is also the first full year in which we will have our expanded AWC sales force in place.This will allow us to continue to meet our commitment to grow this business 3040% in top line sales. Lastly, we have several new exciting private label manufacturing contracts, including our first Medihoney® dressings for the over-thecounter market.The result will be better cash flow from the combined AWC and traditional wound care business. TWC: How is your company unique? EQ: What makes us unique, especially for our size, is our ability to develop and introduce leading brands in AWC, manufacture millions of dressings and bandages under private label manufacturing contracts for other customers in traditional wound care, and run a drug-development business.There are many small companies doing one of the three, but I can’t think of another doing all three and being successful at all of them. TWC: Why are you passionate about the work of your company? EQ: When I started with Derma, we were a handful of people with one product line.Today, we have some of the most experienced and talented people in wound care working on our drug-development team.The talent in our sales organization is outstanding, as the results certainly support. I also have been fortunate to be part

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_Industry_DM.indd 24

of building a management team and a team of employees who I believe are doing the best work in the wound care space. Also, I am proud of providing products that are helping improve the lives of patients. TWC: How is your company approaching challenges in wound care? EQ: Head-on, in everything we do. We’re developing new technology in drugs, dressings, and devices and establishing our brands as “leaders.” We are also providing cost-effective commodity products to our traditional wound care customers. TWC: What are your most popular products and/or services? EQ: Our most popular products at the moment are our Medihoney product line and our TCC-EZ® Cast.They are the key drivers of our AWC growth. Certainly, our most anticipated product is DSC127. There are many people in wound care hopeful that we can produce the results in phase III that we did in phase II and deliver this important drug to patients. TWC: How do you ensure proper training on products and services? EQ: We have a team of nurse clinicians supporting our field sales force and our customers. In addition, the field sales force receives ongoing training across wound care in order to be effective in speaking with our customers not only about our products but how those products fit into the treatment plan for their patients. TWC: What are the future goals for you and your company? EQ: Our goal is to become the leading company providing solutions for AWC management. If you don’t strive to be the best at what you are doing, you probably never will be. n www.todayswoundclinic.com

8/9/13 1:01 PM

industryinsider An Inside Look at MTI Inc.

or this month’s feature, Today’s Wound Clinic spoke with Jeff Baker, president.

Today’s Wound Clinic (TWC): How long have you been in wound care, and how did you enter this area of healthcare? Jeff Baker (JB): Jeff Baker, MTI entered the president wound care space as an extension of our podiatry product line in 2009.There was an unmet need in the industry for exam and procedure chairs and tables that provided exceptional reliability, technological advancements, and ease of use — with comfort, safety, and accessibility for the patient. We’ve also been able to provide a very innovative and successful product designed to help reduce healthcare worker injury from lifting a patient’s legs, which is required for certain procedures. TWC: What’s your day-to-day role? JB: Daily responsibilities can encompass phone calls from international dealers, serving on an American Diabetes Association (ADA) advisory board in Washington, DC, responding to emails from field representatives for customer quotes, setting up a booth at a trade show, recommending product redesign elements to an engineer, or helping pack product for an outbound shipment.Of course, the normal activities of sales analysis, meetings with the senior team, and an occasional lunch also occur. It has been a tremendous success story for me over the recent decades, building a company from scratch.

TWC: What do you find most rewarding about providing for your industry? JB: At the end of the day, my satisfaction 26

is filled when a doctor or clinician compliments our product for its functionality, new design, durability, or the service they received from MTI. In wound care, our specialized bariatric chairs and new Leg Wrapping Supports have been rewarding for me from design to production to delivery to the satisfied customer. It is all about the quality of one’s product or service that speaks volumes.I sleep well at night knowing we’ve accomplished both when it’s reinforced by the customers we serve. TWC: How would you describe the overall mission of your company? JB: MTI is committed to producing high-quality and competitively priced products for the markets we serve while being dedicated to our customers, associates, and community. We seek to be the best in our industry and will always strive to do so by employing qualified and trained associates, listening to our customers’ needs and desires, and never losing our thirst for success. TWC: What’s new with your company in 2013? JB: After rigorous field testing, MTI will introduce some new products for wound care.We are about to release a new and exciting product designed to reduce healthcare worker injury, provide greater accessibility to patients, and improve patient outcomes.We’ve also hired key roles within the company to drive our brand and product globally and to better serve our customers. In short, we are positioning ourselves for the next phase of growth, which is very exciting. TWC: How is your company unique? JB: MTI is proud to be an innovator in the healthcare industry by providing strength in patient care. Our primary

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_Industry_MTI.indd 26

goal is to design and produce the most technologically advanced, durable, reliable, ADA-compliant, and competitively priced products in the industry. Our products are known throughout the industry for their strength, superior quality, and longevity at an affordable price. We were the first American manufacturer to universally employ the use of 24-volt DCpowered motors in the markets we serve. MTI’s low-voltage DC motor technology provides smooth and reliable operation without the use of hydraulic fluids, positioning sensors, or limit switches. We’ve also been awarded several patents and have several more patents pending on devices and accessories designed with the help of surgeons and the physicians we serve. We have more than 75 years of combined industry experience at MTI, and the resulting superior product demonstrates our competitive advantage. TWC: Why are you passionate about the work of your company? JB: I come to work every day excited about the possibility of discovering a new potential for one of our current products or for the chance to solve a systemic or individual problem weighing on one of our current or potential customers. I think the challenge of the work is what motivates me every day. TWC: How is your company approaching challenges in wound care? JB: The first is our decision to enter the market in 2009 at the request of medical professionals who needed our product, and the second is the products we’ve pioneered in the wound care space. MTI’s new Leg Wrapping Support system comes in a chair, hospital bed, and portable version. It is another breakthrough product allowing a single healthcare worker to wrap most patient leg sizes, eliminating the difficulty of supporting a patient’s leg with multiple caregivers. This ergonomic solution for preventing healthcare worker injury has been instrumental.We have also tackled the challenge for bariatric patients by www.todayswoundclinic.com

8/9/13 1:02 PM

industryinsider developing the MTI 527W chair, which lifts 800 lbs. TWC: What are your most popular products and/or services? JB: The MTI 527 Tri-Power and 527W Bariatric Tri-Power chairs. The 527 lifts 650 lbs. and the 527W lifts 800 lbs. Both of these chairs offer auto return; slide-back removable patient arm rests, which are reversible for prone position of the patient; extendable leg rest; a debris tray; and designer or smooth upholstery cushions.

TWC: How do you ensure proper training on products and services? JB: MTI attends more than 40 tradeshows globally each year. We assign our field personnel to these shows to continually learn about our new products, accessories,and features.We also conduct annual national sales meetings over a three-day period where we train our representatives on all aspects of product design, build, and use. Our representatives are well qualified to set up products and train healthcare workers upon purchase of new equipment. They are then evaluated on the process by

the customer.We are constantly evaluating our customer service in regard to delivery, setup, and post-sale training. TWC: What are the future goals for you and your company? JB: I look forward to continue providing leadership to a rapidly growing healthcare company. And we look forward to expanding the specialty markets we now serve by introducing new, innovative products designed with the patient and physician in mind in several specialties yet to be announced. n

Wound Certification Prep Course ™

Prepare For National Wound Care Board Certification Examinations To Advance Your Career.

Select from two different locations in 2013 Las Vegas, NV

September 25 – 26, 2013

Learning Objectives

• Outline the etiology of chronic wounds and extrinsic factors, which contribute to and affect wound healing outcomes. • Describe the phases of wound healing and the associated microenvironment, cellular components and their functions in wound healing. • Identify the anatomy of the skin and other important structures. • Assess research and evidence related to wound management. •D escribe specific diagnostic tests, examination tests, lab tests and measures related to wound assessment and management. • Identify the components of wound assessment and documentation. • Identify methods for recognizing soft tissue and bone infections, bioburden management and treatment of local and systemic infections. • Discuss nutritional factors and the underlying deficiencies that impact wound healing. • Relate the psychosocial and cognitive aspects to patient outcomes in wound repair. • Describe specific treatment interventions for chronic wounds including debridement, topical therapies, biophysical technologies and the use of HBO therapy.

Bally’s Las Vegas

$520*

* $400 – S pecial Pricing for Attendees to SAWC Fall (Las Vegas) * This registration fee is in addition to the normal SAWC Fall pricing.

Newark, NJ

October 26 – 27, 2013 Renaissance Newark Airport Hotel

$520

Faculty AAWC 25% discount Greg Patterson, MD, FACS, CWS Medical Director General and Vascular Surgery, Bariatric and Metabolic Surgery Archbold Center for Wound Management and Hyperbaric Medicine Thomasville, GA

Pamela Scarborough, PT, DPT, MS, CDE, CWS Director of Public Policy and Education American Medical Technologies Irvine, CA

Dot Weir, RN, CWON, CWS Osceola Regional Medical Center Kissimmee, FL

Intended Learners

Co-located with, and held before, the 2013 Symposium on Advanced Wound Care conference (SAWC Fall in Las Vegas), and a second standalone meeting in Newark, NJ.

Course curricula designed for MD/DOs, DPMs, PTs, NP/PAs, RNs, and other healthcare professionals interested in updating their wound care knowledge.

SAWC FALL

Register online at www.woundprepcourse.com or by calling 800-237-7285, ext. 233. Sponsored by North American Center for Continuing Medical Education, LLC

cancellations received in writing before the above date. No refunds will be issued within 30 days prior to each course date – without exception. Registrations are transferable at any time.

Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC) to provide continuing education for the healthcare team.

Cancellation Policy Please note the cut-off date for cancellation is 30 days prior to each course date. All cancellations must be received in writing and postmarked by that date. Full registration (less a $75 processing fee) will be refunded only to

Accreditation Information In support of improving patient care, North American Center for Continuing Medical Education, LLC (NACCME) is accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation

Physicians: NACCME designates this live activity for a maximum of 17.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nurses: This continuing nursing education activity awards 17.0 contact hours. Provider approved by the California Board of Registered Nursing, Provider Number 13255 for 17.0 contact hours.

This program is approved for 17.0 contact hours.

Podiatrists: North American Center for Continuing Medical Education, LLC (NACCME), is approved by the Council on Podiatric Medical Education as a sponsor of continuing education in podiatric medicine.

PHYSICAL THERAPISTS: PARKS Institute will apply for pre-approval accreditation in Texas, Nevada, and New Jersey which require pre-approval. If you practice in another state, please consult its PT board.

For questions regarding this educational activity, please call 609-371-1137.

www.todayswoundclinic.com

XX-XX_TWC_Aug_Industry_MTI.indd 27

Hardware/Software Requirements: All educational activities are accessible via a PC (Windows 2000/XP/Vista/7) or Mac (Mac OS 10.x or later) computer with current versions of the following browsers: Internet Explorer, Mozilla Firefox, Google Chrome or Safari. Windows Media Player or compatible alternative, sound card, and speakers are required for streamed audio. The latest version of the Adobe Flash Player is suggested (please download here) for video programs. A PDF reader is required

for print publications. Please direct technical questions to webmaster@naccme.com.

be reproduced or transmitted in any form or by any means, electronic or mechanical, without first obtaining permission from North American Center for Continuing Medical Education.

Requirements for Credit: To be eligible for documentation of credit, participants must participate in the full activity and complete the evaluation form. ADA Statement: North American Center for Continuing Medical Education complies with the Copyright @ 2013 by North American legal requirements of the Americans with Disabilities Center for Continuing Medical Education, Act and the rules and regulations thereof. If any LLC. All rights reserved. No part of this participant in this educational activity is in need of ® accredited continuing education activity may accommodations, please call 609-371-1137.

Today’s Wound Clinic August 2013 27

8/9/13 1:02 PM

clinician’sreport

Educational Aids & Resources

Wound Care Education Institute (WCEI®)

wound care professionals to stay knowledgeable of the latest clinical advances in treatment options.

Website: www.wcei.net Contact: Mike Grivas, CWCMS, vice president of business

sicians, nurses, physical therapists, researchers, podiatrists, and dietitians who are involved in wound healing or wound care issues. SAWC provides attendees who study and treat wounds with state-of-the-art reviews of clinical problems and research information.

development; 877-462-9234; mike@wcei.net.

Location: Plainfield, IL Founded: 2003 Program Provideded: Skin and Wound Management, Diabetic Wound Management, and Ostomy Management Certification courses

Program Description: WCEI is a dedicated center of education designed to provide licensed healthcare providers with current evidence-based comprehensive training programs in the areas of skin and wound management, diabetic wound management, and ostomy management. In just a few days with our professional instructors, you can develop specialized clinical skills in a curriculum designed to motivate and re-energize you. The national certification exams are sponsored by the National Alliance of Wound Care and Ostomy.™

Target Audience: SAWC conferences are designed for phy-

For More Information: SAWC meetings are multi-day meetings held in the spring and fall. To register or to learn more information, visit www.sawcfall.com or www.sawcspring.com; or call 800-237-7285, ext. 233. n

Wound Clinic Business (WCB)

Website: www.woundclinicbusiness.com Contact: HMP Communications LLC Target Audience: Licensed healthcare providers holding any Location: Malvern, PA of the following credentials — MD, DO, DPM, PA, PT, PTA, Founded: 1987 OT, NP/APN, RN, LPN/LVN. For More Information: Call 877-462-9234; email info@ Program Provided: WCB meetings wcei.net; or visit www.wcei.net. n Program Description: The nation’s premier event devoted

Symposium on Advanced Wound Care (SAWC)

to managing the wound care and hyperbaric oxygen therapy (HBOT) revenue cycles for hospital-based outpatient departments and physicians who work there. Each year, Andrea Clark, a nationally prominent health information management (HIM) expert, and Kathleen Schaum, MS, a nationally recognized wound care reimbursement expert, bring new information on reimbursement and payment policy changes for wound care, HBOT departments, and physicians. Investigate your revenue cycle team’s knowledge of the ideal operational processes by following a patient through initial access/registration, assessment with management documentation requirements, charge capture and diagnosis, and claim submission and payment. Then, further your team’s knowledge on how to conduct internal audits pertaining to wound care and HBOT, and why they’re needed.

Website: www.sawcfall.com; www.sawcspring.com Contact: HMP Communications LLC Location: Malvern, PA Founded: 1987 Program Provided: SAWC Fall and SAWC Spring meetings Target Audience: Medical directors, physicians and podiatrists, Program Description: As the nation’s top two interdis- non-physician practitioners,program directors,clinical managers, ciplinary wound care conferences, SAWC Fall and SAWC Spring meetings provide a venue at which wound care clinicians can advance their knowledge and skills to work toward one common goal: decreasing the number and severity of wounds. With more than 130 clinical session offerings combined, SAWC provides the highest level of clinical education. SAWC hosts a major exhibition of products and services for 28

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_CliniciansReport.indd 28

therapists, billing directors, charge description master directors, HIM directors, coders, office managers, corporate compliance officers, revenue integrity auditors, and hospital executives.

For More Information: WCB meetings are one-day regional meetings held in eight cities around the US. You can learn more by visiting www.woundclinicbusiness.com or by calling 800-237-7285, ext. 233. n www.todayswoundclinic.com

8/9/13 3:40 PM

negativepressure

contiuned from page 23 added to the wound bed and the wound was considered closed in another five days. The infant would have the NPWT in place for 36 days and his abdominal wound closed without any complications. He was kept in the nursery for another four days before being discharged home with a simple, adhesive foam dressing for protection. A home health nurse was employed for approximately two weeks before the parents could assume total care. He returned to the hospital approximately four weeks later for a ventral and right inguinal hernia repair. He was again discharged without further complications after four days.

During the period of NPWT treatment, the infant continued breastfeeding without experiencing difficulties with stooling or gastrointestinal symptoms. Although used at a very low level of suction, the NPWT provided enough therapeutic effect to begin the healing process and completed the granulation of this wound in an additional five days when increased to only 50 mm Hg with the black foam.

Assessing Advantages & Disadvantages of NPWT

The advantages of this therapy for the infant in question were a decrease in the number of dressing changes needed from a minimum of daily to three

weekly, as well as reduction in pain with each dressing change. By the fourth week of NPWT, if a dressing were changed after a feeding, the infant would sleep through the procedure. The biggest challenge with the use of this dressing modality was related to the size of the equipment and dressing supplies. n Carol Price is on staff at the Children’s Hospital of Denver. References 1. Magnuson DK, Parry RL, Chwals WJ. Abdominal wall defects. Perinatal Medicine Diseases of the Fetus and Newborn. 8th ed. Philadelphia, PA: Mosby-Elsevier; 2006: 1306-1308.

Knowledge is power—take some for yourself! Wound Care Education Institute (WCEI®) is a dedicated center of education designed to provide students with comprehensive training programs. Being certified can make a distinct difference in your patient’s life, but it could change yours, too. In just a few days with our professional instructors, you can develop specialized clinical skills in a curriculum designed to motivate and re-energize you. While you learn, you can take advantage of networking and career support opportunities. The National Certification Exams are sponsored by the National Alliance of Wound Care® . In some cases, tuition for WCEI programs may be covered by your employer.

Courses available for: RN’s / LPN’s / PT’s / PTA’s / OT’s / OTA’s / MD’s / DO’s / DPM’s / PA’s

Become Certified in Wound Care

Become Certified in Diabetic Wound Management

Become Certified in Ostomy Management

The Skin & Wound Management Certification course is offered as either an ON-SITE classroom or self-paced, COMPUTER-BASED program. It is designed to educate participants with an overall comprehensive approach to risk assessment, wound assessment and patient treatment plans in wound management.

The Diabetic Wound Management course focuses on overall diabetic wound care and promotion of an optimal wound healing environment including prevention, therapeutic and rehabilitative interventions. The course is offered as both an ON-SITE classroom or self paced, COMPUTER-BASED program.

By becoming an Ostomy Management Specialistsm (OMS), you’ll have the skills to provide compassionate care to an underserved population. The OMS certification class is a comprehensive course of study that will take you from the anatomy and physiology of the systems involved in fecal and urinary diversions, hands-on skills training workshops, through the life-time of care required for the ostomy patient.

2013 CLASS SCHEDULE

2013 PARTIAL CLASS SCHEDULE

AUGUST 5-9 Norwalk, CA San Francisco, CA Woburn, MA 12-16 Manitowoc, WI San Diego, CA 19-23 Philadelphia, PA St. Louis, MO SEPTEMBER 11-15 Las Vegas, NV 16-20 Concord, NH Portland, OR 23-27 Indianapolis, IN Louisville, KY 30-4 Princeton, NJ

OCTOBER 7-11 Kansas City, MO Raleigh, NC Sacramento, CA 14-18 Columbus, OH Lake Geneva, WI Nashville, TN Tempe, AZ 21-25 Denver, CO Irving, TX 28-1 Albuquerque, NM Kingston, NY Windsor, CT

SEPTEMBER 11-15 Las Vegas, NV NOVEMBER 4-8 Philadelphia, PA DECEMBER 2-6 Des Plaines, IL

Mention Coupon Code “WOUNDS” to receive $100 discount off WCC or DWC course registration! Coupon code must be used at time of purchase/registration. Existing registrations are not eligible. Expires 12/31/13

www.todayswoundclinic.com WCEI_HMP_WOUNDS_70113.indd 1

XX-XX_TWC_Aug_Preemie.indd 29

OCTOBER 7-11 East Elmhurst, NY (Registration Deadline 9/7/13) 14-18 Monroe, LA (Registration Deadline 9/14/13) NOVEMBER 18-22 Irving, TX (Registration Deadline 10/18/13)

Visit www.wcei.net for complete class schedules for all 3 courses.

Today’s Wound Clinic® August 2013

6/27/13 4:26 PM

8/9/13 3:44 PM

facilityinfocus Taking a Multidisciplinary Approach to Care at Denver Wound Healing Center Once the region’s only wound clinic, the facility remains a go-to source for many patients with complicated cases.

By Joe Darrah

Presbyterian/St. Luke’s Medical Center, Denver, CO

enver, CO — There were many justifiable reasons to think that Dian Clawson’s wound might never fully heal. More than two months had already passed since her triple bypass surgery when the 74-year-old presented at Denver Wound Healing Center last spring with an infection at the site of the saphenous vein harvesting required for her heart procedure. Measuring 16.5 cm long, 2 cm wide, and 0.5 cm deep, the wound practically ran the length of her left leg. Although she had already received several weeks of negative pressure wound therapy (NPWT), Clawson was afforded very little in the form of guarantees when a quantitative culture taken during her initial assessment revealed MRSA. If the overall severity of the wound didn’t pose enough of a challenge to close, Clawson’s condition was further complicated by a steroid dependency that developed due to her long-term treatment of Addison’s disease, a condition the Centennial, CO, resident has lived with more than 30 years that’s also

photo courtesy of the facility.

led to type 2 diabetes. Between her age, chronic comorbidities, and immunosuppression, it would be daunting to even attempt to consider ranking the severity of each treatment hurdle from a wound care perspective, said Debra Stanley, RN, a staff nurse at the clinic — a comprehensive, multidisciplinary facility housed in Presbyterian/St. Luke’s Medical Center — and the primary nurse assigned to assist Clawson’s wound care planning. “She presented as a very tricky case because there were a lot of puzzle pieces that led her to be a very high risk for infection,” said Stanley, who characterized the wound as one of the most severe that she’s seen. “She’s steroid dependent, she’s diabetic, she was deconditioned physically following her bypass surgery and required a rehab nursing home stay prior to visiting us, there was already an infection to be addressed, and the wound bed wasn’t even ready yet for the placement of the vac [which had been placed previously by another facility],” Stanley continued.

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_FacilityFocus.indd 30

“She presented with a difficult problem for our team to solve, for sure.” Solve it, they did. But not before Clawson, one of three uniquely complex patients at the clinic who recently met with Today’s Wound Clinic during on-site interviews, developed an unrelated case of pneumonia as well as a recurrent case of MRSA. Clawson has since fully recovered, but just as is the case for the other individuals who were willing to share their experiences with TWC, her story is her journey to healing — the common thread being each patient’s path to this wound center — which opened more than 20 years ago as the first specialized wound care clinic in the Denver metro region and today stands as the largest of its kind in the state, offering the services and expertise of more than 12 specialty-certified physicians specializing in general, plastic, and vascular surgery; internal medicine; podiatry; and hyperbaric medicine.

Serving An Unmet Need

At the time Presbyterian/St. Luke’s began operating its wound clinic in 1991, there was a significant lack of comprehensive wound care services available to area residents, who up until that time

From left, Debra Stanley, RN, Dian and Alden Clawson. Jason Grubb Photography Inc.

www.todayswoundclinic.com

8/9/13 3:39 PM

facilityinfocus were relying on inpatient hospital settings and, more likely, private physician practices to conduct their wound treatments. Essentially, there was a groundswell of patients waiting for better quality of wound care from the time the facility opened its doors. “And that’s not to say the clinicians around here didn’t ‘care’ about their patients or that they weren’t providing for them — it was about them not having availability of the appropriate tools that this patient population needs or the time to devote to them,” said Paula Stanton, PT, CWS, MBA, manager of the Denver Wound Healing Center and its accompanying Diabetes Management Center. “There was an unmet need for dedicated wound care services in this region.And we offer a program that’s multidisciplinary and multifaceted — which is what most wounds are. Most patients aren’t going to ‘just have’ a diabetic foot wound. They will also have venous insufficiency, congestive heart failure, and so on.” Case in point: Clawson, who, prior to her arrival to the clinic, had received wound treatment while undergoing postsurgical rehabilitation in a skilled nursing facility. By the time she was referred to the Denver Wound Healing Center, both she and her husband Alden were physically and emotionally worn down from her experience, which began in March 2012 with the heart surgery. “We had some adverse feelings about the care she had received up until then and with what we were dealing with overall,” said Alden. “It was a very stressful and difficult situation.” Given Clawson’s health and the gravity of her complications, the wound clinic staff would suggest a care plan that required her to revert back to “square one” as per its standard of care and general algorithms. Spending more time to seek out a means to healing was all anyone at the clinic could really assure, which, in reality, is all they can promise any patient. (Though, they boast a 16-week, 88.6% healing rate.) But for those patients like Clawson who are living with chronic, complicated wounds that haven’t received the treatment they require and have experienced similar situations in which other providers haven’t been able to give them the answers and hope they’re seeking, the individualized attention, education, and care planning they receive at the clinic is in some ways a cure in and of itself. Consider Jesse Davila and Mary Crooks, two additional clinic patients who met with TWC during our recent trip who’ve had their own circumstances and wounds that have persisted over the last several years.

Devoted to Diabetes

Davila, also a diabetic, is married with three children and was diagnosed with type 2 diabetes in 1999 — on the same day as his father, in fact, in an ironic twist of healthcare fate. However, he believes that he was never appropriately educated about his disease until he was introduced to the wound clinic of his own volition this past fall, when he asked his primary physician for a new wound care referral because he had become fearful that he was not getting the care he needed at another facility. Having lost his right foot to an amputation due to Charcot joint in 2006, Davila, 55, said he decided to switch wound care providers when he was given a “we will eventually have to amputate” assessment for and had been given several debridements. www.todayswoundclinic.com

XX-XX_TWC_Aug_FacilityFocus.indd 31

Belief in Healing ‘All Wounds’ Denver Wound Healing Center physician reflects on clinic’s passion, approach to successful wound care. By Joe Darrah When Paul Thombs, MD, frankly explains, “all wounds are supposed to heal,” he’s not just trying to state the obvious. And he’s hardly passing off a grand generalization that requires no burden of proof. No, when he says that he expects each wound treated at the Denver Wound Healing Center at Presbyterian/St. Luke’s Medical Center to heal, he means it — albeit soft-spokenly. “People are supposed to heal — we’re genetically encoded to heal — so, when a wound is not healing it’s because something is wrong in that process,” said the board-certified hyperbaric physician, one of more than 12 specialty-certified physicians at the clinic, for which he once served as one the founding medical directors when it opened in 1991. “And the key to getting people to heal is understanding what is wrong, why they’re not healing, and how many different issues there are that are keeping them from healing.” At the wound clinic, that understanding is nurtured by a multidiscipline approach to care. “Every patient receives an in-depth nursing and physician assessment, and we start laying out a plan depending on their condition, their history, and the resources that they’ll need in order to heal,” he explained. “If it’s someone whose diabetes is not being well treated, we’ll bring in our diabetes educator. If it’s someone we know is going to need reconstructive surgery or there’s a vascular problem that clearly needs a closer look, we’ll get the plastic or vascular surgeon involved. Our protocol allows all the physicians here to easily refer to one of our other clinicians, and that’s where the nursing overlap also helps because they work with all the physicians and can be pulled into particular cases based on the experiences they’ve had with patients and physicians over the years.” As part of the multidisciplinary-care model, clinic nurses serve as case managers who serve as primary wound care nurses for each physician and patient while coordinating care with other specialists and with patients throughout the course of treatment. The model has proven its worth in producing an overall healing rate of 88.6%. But does that lead to facing expectations that can be difficult to meet? “That’s not so much a challenge as it is an opportunity,” Thombs said. “A patient who has a chronic wound and wants to do something about it — we have a lot of tools in the toolbox for them. What else could you ask for as a provider?” n Today’s Wound Clinic® August 2013

8/9/13 3:39 PM

facilityinfocus

Jodie Royer, RN (left), and her patient Jesse Davila. Jason Grubb Photography Inc.

“They were just debriding, and debriding, and debriding — it was like déjà vu with what happened the first time I had a foot ulcer, and I knew things weren’t going to get better when they told me they ‘didn’t know what else to do,’” said Davila, a Texas native who moved to the Denver region in 1993 after “falling in love” with the area while on vacation. “When they told me that, I knew I had to get out of there, because it was like my foot was just being whittled away.” A resident of Broomfield, CO, Davila said the nearly 50-mile, one-way drive he makes to the clinic is barely noticeable when weighing the benefits of the care and education he has received. As a patient in the Diabetes Management Center, he has received weeks of one-on-one consultation with an endocrine and diabetes specialist as well as education sessions with his wife Joanne, who has also been trained to assess and manage drainage of his wound and help the clinic staff evaluate how often he needs to be seen. Weekly visits have since been reduced to twice per month with the self-care management Davila has been taught. “We know that he’s educated enough that we can rely on him to monitor his condition at home instead of dragging him into the clinic every week,” said Jodie Royer, RN, Davila’s primary nurse. Jesse wants to keep his foot and he’s been willing to do what he can to help us see if we can do that.” Davila, whose ulcer measured 2.6 cm x 4.5 cm when he first presented and 0.3 cm x 0.5 cm at the time of the TWC visit, insists that his willingness to properly self-manage his care has always been there, but that he went years without getting the formal education required 32

to do so. As he sees it, had he been better educated from day one, he may not have lost his right foot or needed a kidney transplant, which occurred in 2008 and landed him an extended hospital stay when MRSA developed after surgery. “I needed to learn how to manage my diabetes,” he said. “Like a lot of people, if you’re not educated, you think that the only thing you have to do is give yourself an insulin injection when your numbers don’t look right. But you’re just masking the problem with the insulin if you’re not taking care of yourself through dieting. I know now that when you get an infection as a diabetic that you have a lot of problems controlling your sugars.” When he was first assessed at the wound clinic, his hemoglobin A1c was at 7.9 but has since been reduced to close to 6. “It’s not exactly where we want it, but it’s closer to what we’re looking for than before he came in,” said Royer. “Because Jesse needs to be monitored closely following his transplant, we’ve discussed that he needs to keep his sugars in check if he wants us to turn everything that we can do for him into wound healing. There’s no telling how long the underlying infection has existed, but I think the biggest thing lacking in his previous care was that it seems nobody conducted a quant culture, which allowed us to give him the PO antibiotics, because it showed positive for bacteria, and move forward systemically. Or, it might be that the wound previously was being cleaned too much.There’s a fine balance between cleaning too much because you can lose too much granulation tissue there.” Once confined to a wheelchair, Davila now ambulates with the help of a prosthetic and is able to remain active with his kids. He credits the wound clinic and his care providers for that. “I’m not an indoor, watch-TV type of guy,” he said. “From the time I got here I’ve been learning and seeing my infection being treated and improving. If I didn’t come here I don’t know if my infection would be addressed.” Mary Crooks, a patient in the clinic who’s being treated for a rare skin condition, can relate to exactly that sentiment. Forced into an early retirement due to

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_FacilityFocus.indd 32

a chronic case of sporotrichosis (commonly referred to as rose-picker’s disease), Crooks, 71, went undiagnosed with the ailment for nearly two years, seeing multiple dermatologists and infectious disease specialists, before she was referred to the wound clinic in spring 2011. But the depths to her declining health run decades long and actually started with a dental procedure.

Treating Rare of Infections

It was 1995 when Crooks had what was thought to be an otherwise routine root canal procedure. In the ensuing days, however, she developed an abscess on her chin that formed a draining sinus that required surgery to remove. The surgery seemed successful, but an undiagnosed case of actinomycosis persisted and migrated to the left side of her face — where multiple, painful fistulas developed that she unsuccessfully attempted to cover up with Band-Aids and makeup. By the time she received the correct diagnosis about four years later, there was little that the oral and IV penicillin could do to repair the damage beyond eliminating the actual bacteria, and plastic surgery was needed — which include grafting and partial removal of her face. … And that’s still not where her problems ended. Enter the sporotrichosis. “Shorty after the plastic surgery procedure, I was out picking flowers with my granddaughter out front of my house, and let her wear my gloves because she didn’t have any and her hands were getting dirty,” Crooks related. “My niece was getting engaged and we thought the flowers would be a nice gift for her. It was just so innocent — and the worst part of it is, I don’t even like gardening.”

Patient Mary Crooks with husband Bob and nurse Ann Page, RN, CWS. Jason Grubb Photography Inc.

www.todayswoundclinic.com

8/9/13 3:39 PM

facilityinfocus Immunocompromised due to her prior infection, Crooks was vulnerable to the sporotrichosis, which is caused by a fungus that lives in soil, plants, and decaying vegetation. The infection would eventually spread from her fingers and up both arms in the form of painful, raised ulcers. “I went to a variety of doctors and specialists and had been from clinic to clinic,” said Crooks, adding that many providers suggested she was experiencing Munchausen syndrome, a mental health disorder characterized by self-infliction of wounds and delusions of being ill. In all, she estimates living with the sporotrichosis infection eight years and would end her career as the senior vice president of a local financial services company early to “commit full time” to locating someone who could find her a cure. “I had a career that I really enjoyed and continued to work as long as I could, but it just became too much to deal with,” she continued. “I also have five grandchildren, and I didn’t want them to think of me as an invalid. By the time I got here, I was in so much pain and was so demoralized and depressed with my history that I needed to be in a wheelchair. I hate to think it, but I was beginning to give up hope.” Though Crooks said she had been adamant with every provider she met about sporotrichosis after reading about its symptoms online, it was often dismissed until she found the wound clinic — on a dermatologist’s referral. “We see a lot of unusual wounds here, and we have the forte from experience to identify them and deal with them,” Stanton said. Cared for by Robert Carson, MD, board-certified in internal medicine, Crooks received a high dose of Sporanox and intravenous immunoglobulin (IVIG). Results came gradually, but were evident. Her husband Bob was also a driving force of support the entire time. “Mary had a very long and involved wound history, so she’s had a couple of underlying problems that’s affected things, but the IVIG really helped her turn the corner,” Stanton continued. “And with the volume of patients we see, we’re bound to see a variety of conditions. We go through our standards of practice by addressing compression, circulation, and infection — and if something isn’t working as well as we’d like, we can actually look back on other cases that we’ve seen. It’s very helpful to be able to see enough patients that your memory can be triggered by particular patients and particular wounds.”

Just Your Basic “Gold” Standards

And then there’s Clawson, whose case actually led the clinic to investigate a plan of care borrowed from evidencebased practice. Upon her initial assessment, Bryan Kramer, MD, FACS, one of four board-certified vascular surgeons at the clinic, ordered a quantitative tissue biopsy/culture, which has generally become accepted as the “gold standard” for evaluating the presence of microorganisms. Clawson’s NPWT was immediately discontinued, as it was deemed to have been applied to the wound bed prematurely. www.todayswoundclinic.com

XX-XX_TWC_Aug_FacilityFocus.indd 33

Revamping Neonatal Wound Care Presbyterian/St. Luke’s enhanced NICU adds to wound care clout. By Joe Darrah This summer, the Rocky Mountain Hospital for Children at Presbyterian/St. Luke’s Medical Center, Denver, CO, strengthened its impact on the field of pediatric wound care with the expansion of its NICU. With an ever-increasing caseload of newborns requiring wound care services, the upgrade was needed not just to meet the demands of a patient population that spans a seven-state region — and travels from as far as Wyoming and New Mexico to be cared for by the renown pediatric referral center — but to foster an environment that’s expected to produce industry-breaking evidence-based research and practice. Though they haven’t had much time to get acquainted with their new space, which opened July 10 and has now grown to 84 beds, the NICU’s nurses who comprise its “skin care committee” are undertaking a study that will consider optimal skin care treatments for premature infants. Patricia Thewes, RNC, expects their results will be of great use to hospitals across the nation. “Our unit wants to be on the cutting edge — to be a leader in this area,” said Thewes, a NICU nurse who helped create the unit’s skin care committee, which includes nine nurses (including managers) who meet regularly to discuss possible changes to unit policies and procedures and review evidencebased research findings that could support patient protocols. “I’m really proud of our team and the backup that we have from our nurse practitioners and neonatologists,” said Thewes, who’s also a member of the hospital’s pressure ulcer team that each quarter examines all NICU babies at risk for pressure ulcers due to their size and inability to reposition themselves. Also, with the “mile high” altitude, many newborns are high risk for skin breakdown on their nares, ears, coccyx, and occipital area because of limited positioning. A nurse with nearly 20 years of wound care experience, Thewes has also been instrumental in the development and re-writing of overall skin care in the NICU over the last six years, such as protocols and timelines for dressings, when ostomies should be changed, and troubleshooting with G-tubes for skin breakdown. “We’ve come up with a care plan sheet for ostomies, Gtubes, surgical wounds, and IV infiltrates; and the skin care team follows up with nurses who are caring for these patients to make sure protocol is being followed,” she said, adding that education plays a large role on the unit. As such, all NICU nurses are now required to attend skin care in-services from changing of nasal cannulas to dressings and new protocol. Annual competencies and skills checks are also held, as are educational sessions that provide oversight, guidance, and review of procedural steps for care planning until they’re performed correctly. “I think we’re helping people to be more aware of how fragile the skin can be with the patients they care for,” she said. “Especially with our new grads.” n Today’s Wound Clinic® August 2013

8/9/13 3:39 PM

facilityinfocus “We basically took five steps backward in order to move forward with her because we needed to get the wound bed ready to respond to the wound vac through debridement and get the wound cleaned out,” Stanley said.“We just wanted to pay attention to our algorithms, which is to design a treatment plan to care that’s unique to the wound and etiology.” Clawson was placed on a bleach-based Anasept gel and scheduled for sharp debridement; however, conditions would be further hindered when she was diagnosed with pneumonia soon after her first visit, which landed her back in a hospital, stalled debridement for two weeks, and kept her out of the wound clinic for nearly another month. Upon her return in late June, she was placed in single-layer compression and had NPWT reinserted. By mid-August the wound had shown significant improvement with a measurement of 13.6 cm x 1.9 cm x 0.02 cm,

but would suddenly stall and show no signs of further improvement over her next two visits, prompting another culture that revealed the re-emergence of MRSA. Admittedly, the staff was puzzled. “We weren’t sure why the MRSA returned — we just know it’s something that is a serious problem for hospitals and in the community setting everywhere,” Stanley said. “And we knew that since she was so fragile with her overall health that we needed to pull together as a team to decide how we might mange her care better and think of ways to decolonize her.” An investigation into evidence-based practices turned up interesting results from a study released in 2012 conducted by HCA Healthcare that showed a 44% reduction in MRSA and other bloodstream infections among ICU patients who are universally decolonized. “The study interested us because it used a topical agent,” said Stanley, refer-

ring to a chlorhexidine antiseptic soap, that when combined with the swabbing of patients’ noses with mupirocin ointment, specifically reduced the number of individuals harboring the antibioticresistant bacteria by 37%. The success seen by Clawson was quickly apparent, Stanley said. “Because we were willing to dig a little deeper and use the study as a framework, we were able to eradicate it completely and heal the wound,” she continued, adding that a focus on education also contributed. “Not only did we teach Alden and Dian how to deal with MRSA in the home, we taught the home-care services staff to be our eyes and ears in the home. But we knew what we were trying was evidence-based, and everyone was striving for the same goal.” n Joe Darrah is managing editor of Today’s Wound Clinic.

TWCnewsupdate

KCI Acquires Systagenix for $485 million Kinetic Concepts Inc. (KCI), San Antonio, TX, has signed a definitive agreement to acquire United Kingdombased Systagenix, a provider of advanced wound care (AWC) products, in a move that’s expected to augment KCI’s global position as a leading wound care company with a diverse product portfolio. According to KCI officials, the purchase will cost $485 million. “The acquisition of Systagenix advances our strategy and vision as the global leader in transformational healing solutions,” said Joe Woody, president and CEO at KCI. “This major strategic investment will diversify KCI’s global portfolio of wound care products and reinforces our competitive advantage as the trusted ‘gold standard’ in wound healing. The combination of KCI and Systagenix creates a winning platform across the entire wound care continuum. It increases our ability to address the complete wound healing needs of clinicians and their patients with best-in-class out34

comes that help to reduce the overall cost of patient care.” The transaction also provides KCI with increased access to the $3.4 billion AWC market, which reportedly has an overall category growth of 3-5%. Systagenix has a meaningful presence in the AWC market and is the market leader in collagen dressings, officials said. Moreover, as part of KCI, Systagenix’ strength in the growing categories of foam and contact layers can be leveraged to capture increased market share. Many of Systagenix’ products are complementary and are often used before, during, and after use of KCI’s core negative pressure wound therapy (NPWT) products. The acquisition builds on KCI’s recent acquisition of the CelluTome™ System epigrafting technology. Systagenix includes a broad portfolio of AWC products with a focus on moist wound healing dressings – including PROMOGRAN PRISMA,® reportedly the collagen dressing market leader; TIELLE,® (foam) and ADAPTIC® (non adherent contact layers). Systagenix’

August 2013 Today’s Wound Clinic®

XX-XX_TWC_Aug_FacilityFocus.indd 34

distributes more than 20 million AWC dressings each month to more than 100 countries. The company, formerly part of Johnson & Johnson, has approximately 800 employees worldwide, including an experienced team of research and development scientists. In connection with the transaction, One Equity Partners LLC (OEP) will spin off an early-stage diagnostics business out of Systagenix, which will be held and operated by OEP as a standalone business following the acquisition. In addition, KCI will enter into a long-term strategic relationship with the diagnostics business for the distribution of WOUNDCHEK™ Protease Status. WOUNDCHEK is the flagship product of the Systagenix diagnostics business, designed to help clinicians rapidly assess and target AWC therapies more effectively. The acquisition is subject to customary closing conditions, including applicable antitrust approvals, and is expected to close in the fourth quarter of 2013. n contiuned on page 36 www.todayswoundclinic.com

8/9/13 3:39 PM

TWCnewsupdate continued from page 34

Wound Ostomy Nurses Produce Outcomes, Study Claims The Wound, Ostomy and Continence Nurses Society™ (WOCN®) has released the results of a recent research study that reportedly shows wound, ostomy, and continence (WOC) nurses play key factors in achieving better patient outcomes related to WOC conditions. The study, “Effectiveness of Wound, Ostomy and Continence Nurses on Agency-Level Wound and Incontinence Outcomes in Home Care,” is said to be the largest, most comprehensive study undertaken on WOC care. Results also found that facilities with WOC nurses had significantly better patient improvement and stabilization in services for wounds, incontinence, and urinary tract infections compared to facilities without WOC nurses, officials said. In the more than 400,000 episodes of care included in the study, home healthcare (HHC) patients treated by a WOC nurse improved dramatically compared to HHC patients without a WOC nurse. The numbers find patients were also more than 2.3 times as likely to have stabilization of urinary incontinence, 1.2 times as likely to have stabilization of urinary tract infections, and 1.16 times as likely to have stabilization of fecal incontinence. “WOC nursing is a multifaceted, evidence-based practice incorporating a unique body of knowledge that adheres to high standards of practice cultivated by the American Nurses Association,” said Kate Lawrence, MSN, RN, CWOCN,

president of WOCN. “This study proves that WOC care results in better patient outcomes, which translates into lower patient care costs.” In addition to the aforementioned results, the study also found that patients were nearly twice as likely to have improvement in pressure ulcers, 20% more likely to have improvement in lower extremity ulcers, and 14% more likely to have improvement in bowel incontinence. “WOC nurses are invaluable to employers,” Lawrence said. “Evidence from our study showed that patient outcomes improve and WOC care can prevent readmissions. WOC care also helps ensure home care agencies get the maximum payout from Medicare and Medicaid.” The study was funded by a WOCN grant to a team of investigators at the University of Minnesota School of Nursing. Chartered in 2010, the study successfully met its goals to compare both incidence and patient outcomes in pressure ulcers, stasis ulcers, surgical wounds, urinary/bowel incontinence, and urinary tract infections for patients and facilities with and without WOC nurses, officials said. “We’ve always assumed that WOC education and certification make a difference,” said Bonnie Westra, PhD, RN, FAAN, FACMI, associate professor at the University of Minnesota School of Nursing. “We now have evidence that proves they make a difference.” n

Children’s Hospital Launches Pediatric Ulcer Program A new study has led one pediatric facility to change its protocols for how children are cared for after it was learned that too many kids were experiencing pressure wounds. Researchers at Cincinnati Children’s Hospital Medical Center have reportedly uncovered a high number of children living with pressure ulcers, and they claim the cause is associated with the use of medical devices such as facemasks used for delivering mechanical ventilation, tracheotomy tubes, pulse oximeters, and orthopedic casts. A recent study at the facility included the development of a quality-improvement initiative that has reduced pressure ulcers at the medical center by 50%, according to officials. A host of solutions are said to have resulted in a 50% reduction in pressure ulcers in the pediatric ICU one year after implementation and are expected to be adopted by other hospitals. “While often life-saving, these devices can cause pressure ulcers that can be quite serious,” said Marty Visscher, PhD, director of the skin sciences program at Cincinnati 36

Children’s and lead author of the study, which was preceded by an unscientific survey taken at the hospital that reportedly revealed a rate of pressure ulcers in children of at least 10%, more than twice as high as was thought to occur in pediatrics. “Their incidence is higher in critically ill patients, with increased infection, pain, and prolonged hospitalization,” Visscher said. Cincinnati Children’s also assembled a patient-safety collaborative to investigate the problem. While more than 70% of pressure ulcers in adults occur due to pressure over bony parts of the body, researchers discovered most of those in children occur due to medical devices. “While this initial intervention has proved to be efficacious, we need to use established skin evaluation methods, identify early tissue changes, and test additional interventions to reduce harm from medical devices,” Visscher added. “The unanticipated increase in pressure ulcers from pulse oximeters indicates that new products must be evaluated before widespread use.” A pediatric advanced wound and skin service that includes wound treatment throughout the medical center has also been launched at the hospital, as well as academic research on skin and wound healing, according to officials. n

August 2013 Today’s Wound Clinic®

36-39_TWC_August_News.indd 36

www.todayswoundclinic.com

8/9/13 3:17 PM

TWCnewsupdate Wound Clinic Nurse Joins Haiti Mission Michele Slootmaker, BSN, RN, was recently among a group of healthcare professionals who cared for children during a medical mission trip to Haiti. It was her first mission trip, which she joined through her involvement with her Denville, NJ-based church. The healthcare team treated more than 300 patients over a three-day period, offering care in clinics, including those set up in orphanages, according to a report by NorthJersey.com. A nurse at Chilton Hospital’s Comprehensive Wound Healing and Hyperbaric Center, Pequannock, NJ, Slootmaker was stationed near the city of Cap-Haitien in northern Haiti, a poverty-stricken community. She was also accompanied by her husband Andrew, a chiropractor. n

Photo courtesy of Chilton Hospital

Report Claims Ultrasound Could Cure Leg Ulcers Chronic venous ulcers have reportedly been successfully healed by direct application of low-frequency and low-intensity ultrasound, according to a small pilot study conducted by Drexel University, Philadelphia. Photo courtesy of Drexel University The study included five patients whose lower extremity ulcers were treated with 20 kHz for 15 minutes and completely healed in four weeks. The effect size for that 20 kHz/15 minute treatment was large, at 0.96, when compared with sham ultrasound treatment, and no adverse effects were seen, the researchers, led by Peter A. Lewin, PhD, reported in the August issue of Journal of the Acoustical Society of America. Previous studies had suggested the possibility of therapeutic utility for ultrasound in wound healing, but have used high frequencies ranging from 1-3 mHz, and definitive evidence has been lacking. For the study, researchers enrolled 20 adult patients living with venous ulcers of at least 2 months’ duration and a CEAP (clinical severity, etiology, anatomy, pathophysiology) venous wound classification of 6. Patients all reportedly had standard wound care including debridement and compression, and were randomized to one of four ultrasound groups: 20 kHz for 15 minutes, 20 kHz for 45 minutes, 100 kHz for 15 minutes, or sham. Treatment was given once weekly. The intensity level of 100 mW/cm2 was chosen because the American Institute of Ultrasound in Medicine has deemed that to be safe even for lengthy exposure times. Other ultrasound parameters were a pulse repetition 38

frequency of 1 Hz and a 50% duty cycle. The batterypowered ultrasound applicator, wrapped in sterile dressing, was placed on the wound and held in place with surgical tape. Whereas all five patients in the 20 kHz/15 minute group achieved complete healing, only two patients in the 100 kHz/15 minute and sham groups healed, as did only one in the 20 kHz/45 minute group. During the monthlong treatment, healing was significantly faster in the 20 kHz/15 minute group than in the other groups (P<0.03), the researchers said. Some decrease in wound size did occur in the 100 kHz/15 minute and 20 kHz/45 minute groups, but the rate of change was not statistically different from the rate in the sham group, which actually showed a weekly increase of 3%. Researchers also noted that the ulcers in the sham group were virtually identical in size at baseline to those in the 20 kHz/15 minute group (4.7 cm2 versus 4.8 cm2), “showing that wounds of the same size, when treated with ultrasound did heal, whereas those not treated did not heal,” Lewin said. To further examine the effects of ultrasound at the cellular level, researchers also conducted in vitro experiments in which cultured mouse fibroblasts were exposed to 20 kHz for 15 minutes at intensities of 100, 50, or 200 mW/cm.2 Compared with control cells, the fibroblasts exposed to 20 kHz/15 minute at 100 mW/cm2 showed a 35% increase in proliferation (P<0.01), researchers reported. They also noted that there was no evidence of cellular damage in these experiments and plan to do further experiments examining the effects of ultrasound on collagen,“as collagen production leads to the extracellular matrix comprising granulation tissue, which predominates the proliferative phase of wound healing,” according to Lewin. The study was supported by the National Institutes of Health and three of the authors reportedly received support from Drexel University’s Calhoun Biomedical Engineering Endowment. The study was said to be limited by its small size. n

August 2013 Today’s Wound Clinic®

36-39_TWC_August_News.indd 38

www.todayswoundclinic.com

8/9/13 4:37 PM

TWCnewsupdate FDA Issues Warning Regarding Illegal Diabetes Treatments The US Food and Drug Administration (FDA) has taken action to remove illegal diabetes-care products, including some items labeled as “dietary supplements,” that claim to mitigate, treat, cure, or prevent diabetes and related complications from the market. The agency recently issued letters warning 15 companies that the sale of their illegally marketed products violates federal law.The letters were sent to foreign and domestic companies whose products were sold online and in retail stores. FDA officials are also advising consumers not to use these or similar products because they may contain harmful ingredients or may be otherwise unsafe, or may improperly be marketed as over-the-counter products when they should be marketed as prescription products. Using these products could cause patients to delay seeking proper medical treatment for their diabetes, FDA officials said. “Diabetes is a serious chronic condition that should be properly managed using safe and effective FDA-approved treatments,” said FDA commissioner Margaret A. Hamburg, MD. “Consumers who buy violative products that claim to be

treatments are not only putting themselves at risk, but also may not be seeking necessary medical attention, which could affect their diabetes management.” Many of the illegally sold products that are the subject to the FDA’s actions include claims such as “prevents and treats diabetes,” and “can replace medicine in the treatment of diabetes.” In addition, some of the products may cause harm because the products contain undeclared active drug ingredients or may not have been manufactured and handled according to FDA quality standards. The FDA has requested a written response from these companies stating how they will correct the violations. Failure to promptly correct the violations may result in legal action,including product seizure, injunction, and/or criminal prosecution. As of the issued warnings, FDA officials said they weren’t aware of any reports of injury or illness associated with the illegally sold products. The FDA asks healthcare professionals and consumers to report any suspected associated adverse reactions to www.fda.gov/medwatch/report.htm. n

Classified

www.todayswoundclinic.com

36-39_TWC_August_News.indd 39

Today’s Wound Clinic®

August 2013

8/9/13 4:37 PM

Advertiser’s Index Derma Sciences (TCC-EZ)..........................................................................................................................Cover 2 Equinox Medical LLC (NPWT)............................................................................................................................... 9 KCI (Graftjacket)..........................................................................................................................................Cover 3 Medela (Invia)......................................................................................................................................................... 3 Net Health (WoundExpert)..................................................................................................................................... 5 Novadaq (Luna).................................................................................................................................................... 3 5 Organogenesis (Apligraf).......................................................................................................................Cover 4, 40 Sechrist Industries (HBOT).................................................................................................................................. 15 Shire Regenerative Medicine (Dermagraft)....................................................................................................21, 22 Spiracur (SNaP)................................................................................................................................................... 13 Systagenix (PROMOGRAN & PROMOGRAN PRISMA)..................................................................................... 19 Wound Care Education Institute (Certification Courses).................................................................................... 2 9

Apligraf® Essential Prescribing Information Numbers in parentheses ( ) refer to sections in the main part of the product labeling. Device Description: Apligraf is supplied as a living, bi-layered skin substitute manufactured from cells processed under aseptic conditions using neonatal foreskin-derived keratinocytes and fibroblasts with bovine Type I collagen. (1) Intended Use/Indications: Apligraf is indicated for use with standard therapeutic compression in the treatment of uninfected partial and/or full-thickness skin loss ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy. (2) Apligraf is indicated for use with standard diabetic foot ulcer care for the treatment of full-thickness foot ulcers of neuropathic etiology of at least three weeks duration, which have not adequately responded to conventional ulcer therapy and extend through the dermis but without tendon, muscle, capsule or bone exposure. (2) Contraindications: Apligraf is contraindicated for use on clinically infected wounds and in patients with known allergies to bovine collagen or hypersensitivity to the components of the shipping medium. (3, 4, 5, 8) Warnings and Precautions: If the expiration date or product pH (6.8-7.7) is not within the acceptable range DO NOT OPEN AND DO NOT USE the product. A clinical determination of wound infection should be made based on all of the signs and symptoms of infection. (4, 5) Adverse Events: All reported adverse events, which occurred at an incidence of greater than 1% in the clinical studies are listed in Table 1, Table 2 and Table 3. These tables list adverse events both attributed and not attributed to treatment. (6) Maintaining Device Effectiveness: Apligraf has been processed under aseptic conditions and should be handled observing sterile technique. It should be kept in its tray on the medium in the sealed bag under controlled temperature 68°F-73°F (20°C-23°C) until ready for use. Apligraf should be placed on the wound bed within 15 minutes of opening the package. Handling before application to the wound site should be minimal. If there is any question that Apligraf may be contaminated or compromised, it should not be used. Apligraf should not be used beyond the listed expiration date. (9) Use in Specific Populations: The safety and effectiveness of Apligraf have not been established in pregnant women, acute wounds, burns and ulcers caused by pressure. Patient Counseling Information: VLU patients should be counseled regarding the importance of complying with compression therapy or other treatment, which may be prescribed in conjunction with Apligraf. DFU patients should be counseled that Apligraf is used in combination with good ulcer care including a non-weight bearing regimen and optimal metabolic control and nutrition. Once an ulcer has healed, ulcer prevention practices should be implemented including regular visits to appropriate medical providers. Treatment of Diabetes: Apligraf does not address the underlying pathophysiology of neuropathic diabetic foot ulcers. Management of the patient’s diabetes should be according to standard medical practice. How Supplied: Apligraf is supplied sealed in a heavy gauge polyethylene bag with a 10% CO2/air atmosphere and agarose nutrient medium. Each Apligraf is supplied ready for use and intended for application on a single patient. To maintain cell viability, Apligraf should be kept in the sealed bag at 68°F-73°F (20°C-23°C) until use. Apligraf is supplied as a circular disk approximately 75 mm in diameter and 0.75 mm thick. (8) Patent Number: 5,536,656 Manufactured and distributed by: Organogenesis Inc. Canton, MA 02021 REV: December 2010 300-111-8

August 2013 Today’s Wound Clinic®

40_TWC_August_AdIndex.indd 40 16-00211D_APL_R4_TurnHealingOn Journal Ad_CommonSize.indd 2

www.todayswoundclinic.com

8/12/13 9:11 AM 4/29/13 9:37 AM