iWounds News Issue 3

June 2020 | Issue 03

How COVID-19 is changing wound care: Triage, diabetic inflammation, and the need for international consensus Speaking from their respective homes, William Ennis (University of Illinois, Chicago, USA), Desmond Bell (founder and president of the Save a Leg, Save a Life Foundation, Ponte Vedra Beach, USA), Michael Edmonds (King’s College Hospital, London, UK), and William Li (CEO, president, and medical director of the Angiogenesis Foundation; Harvard Medical School, Cambridge, USA) expounded over video call on the myriad ways in which COVID-19 had impacted multidisciplinary wound care, both in terms of the disruption the pandemic had caused to their daily practices, and how the echoes of this disruption will ripple into the future. They also touched on the interrelationship between diabetes and COVID-19, questioning what the downstream effects will be in the vulnerable diabetic population.

William Ennis:

COVID-19’s impact on wound care

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Thomas Serena:

Profile

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Randomised trial of skin cell suspension confirms efficacy for healing venous ulcers

Use of autologous skin cell suspension (ASCS) in addition to compression has been shown to accelerate healing in large venous leg ulcers (VLUs), according to the results of a multicentre, randomised trial conducted in the UK. Writing in the International Wound Journal (IWJ), investigators confirm that the method represents a “a safe and effective approach for treatment of VLUs” and is capable of improving health-related quality of life.

AS PAUL HAYES (St John’s Innovation Centre, Cambridge, UK) and colleagues explain, ASCS can be prepared in a clinical setting using the RECELL Autologous Cell Harvesting Device (AVITA Medical), allowing the dispersion of single cells across the surface of the wound bed. “In addition to the placement of skin cells where they are needed, the disaggregation process may induce changes normally associated with loss of contact inhibition, thereby activating cellular processes associated with Continued on page 4

ENNIS, WHO IS PRESIDENT OF THE American College of wound healing and tissue repair and chief medical officer at Healogics, moderated the panel discussion.

How has clinical practice been impacted by COVID-19?

Ennis first detailed how in the USA, practitioners were asked to shut down their outpatient services, and were told that there was a difference between essential and non-essential services, but, in his opinion, “there was not a great deal of clarity or granularity as to what defines that and who makes those decisions. […] We personally felt like we were left to figure out our own triage system”.

Bell reported the same experience in Jacksonville, USA. “Nobody really saw this coming, obviously. We

have been left on our own to figure it out.

“Initially, we kept patients out of clinic. […] I think the full impact is still yet to be felt as to some of the long-term implications. We may see a spike in hospitalisations for infections and that type of thing from that two to three-week period where patients were not coming in to clinic.”

Detailing the response of the National Health Service (NHS) in the UK, Edmonds explained that there was a more centralised approach than in the USA, but the directives were similar: “We had a mandate to differentiate between life- and limb-threatening conditions and other diabetic foot conditions, which we could treat in the community, out of the clinic. We had to preserve resources for the hospital itself. From the beginning of March, there was an avalanche of Continued on page 5

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June 2020 | Issue 03

Triage in the age of COVID-19

US podiatrists outline triage system and community care focus to combat COVID-19 “Our goal is to reduce the burden on the healthcare system by keeping patients safe, functional, and at home during the COVID-19 pandemic,” state the authors of a new viewpoint published in the Journal of the American Podiatric Medical Association. Outlining the role of podiatry in these challenging times, Lee C Rogers (Amputation Prevention Experts Health Network, Los Angeles, USA), Lawrence A Lavery (UT Southwestern, Dallas, USA), Warren S Joseph (Editor, Journal of the American Podiatric Medical Association, Bethesda, USA) and David G Armstrong (Keck School of Medicine, University of Southern California, Los Angeles, USA) emphasise the importance of preventing hospitalisations, and reducing both amputation and death, in people with diabetes.

“T

he COVID-19 pandemic is driving significant change in the healthcare system and disrupting best practices for diabetic limb preservation,” Rogers et al emphasise, noting that patients with diabetes and foot ulcers now find themselves at an “increased risk” of infection, hospitalisation, amputation, and death.

Although podiatric care, as the authors acknowledge, is associated with fewer amputations as a result of diabetes, it has been recognised that podiatrists “must mobilise and adopt the new paradigm of shifts away from hospital care to community-based care”. Rogers et al continue: “Implementing the proposed Pandemic Diabetic Foot Triage System, in-home visits, higher acuity office visits, telemedicine, and remote patient monitoring, can help podiatrists manage patients while reducing the COVID-19 risk.”

Triage system

In the face of “drastic containment and mitigation measures”, the authors posit that fragile patients could be left without necessary services, with wound care centres closing or significantly reducing their opening hours. Equally, Rogers et al highlight that procedures and surgeries for the treatment of diabetic foot ulcers may be “misclassified as non-essential”, also depriving patients of the podiatric care they require.

Underlining “the importance of podiatry’s role in unburdening the system”, as well as meeting patients’ needs, the authors strongly recommend the use of a new triage system for lower-extremity wounds and diabetic foot problems: For 94% of patients with diabetes—including those with uncomplicated venous leg ulcers, recently healed foot ulcers and healed amputation—treatment at home and via telemedicine is advised (Stable; Priority 4).

In a further 3% of diabetic patients, visits to the podiatrist’s office are recommended in addition to treatment at home and through telemedicine, which accounts for those with improving, but not healed, foot ulcers, and those with inactive Charcot foot who are not yet in stable footwear (Guarded; Priority 3).

In 0.75% of patients with diabetes, which includes those affected by chronic limb-threatening ischaemia (CLTI), osteomyelitis, active Charcot foot, and worsening foot ulcers, it is recommended that they are given care at an outpatient clinic, office-based lab, surgery centre or podiatrist office (Serious; Priority 2).

For 0.25% of patients, with severe (and some moderate) infections, sepsis or gas gangrene, and acute limb-threatening ischaemia, admission to hospital remains the recommendation (Urgent; Priority 1).

On this system, the authors write: “We have identified the following changes in the healthcare system impacting podiatrists and their patients and recommend strategies to perform best practices in the new pandemic standard of care for the at-risk diabetic foot.”

The COVID-19 pandemic is driving significant change in the healthcare system and disrupting best practices for diabetic limb preservation.”

News in brief

The latest stories from the world of Wounds

n WHIST TRIAL: It is believed that new techniques for wound management, such as incisional negative pressure wound therapy, have potential for reducing the rate of infection, though the evidence for trauma patients is limited.

“The aim of this randomised clinical trial [the WHIST trial],” write Matthew Costa et al, “was to determine if incisional negative pressure wound therapy was more effective than standard wound dressing in reducing the rate of deep surgical site infection”.

Read more on page 6 n WOUND CARE AND COVID-19: In the face of the rapidly evolving COVID-19 pandemic US hospitals and acute care facilities are changing operating procedures in preparation for the expected influx of infected patients.

Services, procedures, and surgeries that are deemed “non-essential” are being shut down immediately, “without thorough consideration of the ramifications” says the Alliance of Wound Care Stakeholders, a multidisciplinary trade association who are “working to ensure that the health of…patients is protected during the COVID-19 crisis”.

Read more on page 7 n SINGAPORE PERSPECTIVE: A rising trend in the burden of wounds upon healthcare systems in Singapore has been revealed by a five-year population review, one of few published studies to focus on the impact of wounds in the Tropics. Investigators Zhiwen J Lo et al underline the cost and length of care, underlining that “in 2017, the average length of stay for each wound episode was 17.7 days”.

Read more on page 12

Continued on page 6

www.iwoundsnews.com Editors-in-chief: Michael Edmonds William Ennis Keith Harding Thomas Serena

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June 2020 | Issue 03

Venous ulcers

Randomised trial of skin cell suspension confirms efficacy for healing venous ulcers Continued from page 1

wound healing.”

According to the authors, applications of ASCS are employed frequently in burn care, promoting epidermal regeneration in deep partial-thickness and full-thickness injuries. “More recently,” Hayes et al continue, “ASCS has been used to benefit patients who have ulcers of various aetiologies, including VLUs and diabetic foot ulcers.”

It has been observed by investigators of previous studies that the application of ASCS can restart healing of wounds such as VLUs, by modulating the wound environment and providing healthy cells.

Although previous investigations into the use of ASCS for the treatment of chronic wounds have demonstrated the potential of the technique, it has not been evaluated in comparison to standard compression therapy in a randomised trial.

The aim of this study, a multicentre, prospective, randomised controlled clinical trial, was to “evaluate the preliminary effectiveness and safety associated with the use of ASCS for the treatment of chronic leg ulcers associated with venous insufficiency”. Hayes et al write that patients with open leg ulceration were recruited from six sites in England and one site in France between July 2013 and November 2015, with an

inclusion criteria of ulcers present for at least four weeks and with an area of 2–80cm2.

Furthermore, all subjects underwent clinical assessment and ankle-brachial pressure index (ABPI) measurements to confirm eligibility (ABPI<0.8), with the trial also requiring patients to have confirmed, managed venous reflux and an ulcer defined as a C6, according to the CEAP (Clinical, Aetiology, Anatomy, and Pathophysiology) classification system.

Overall, 52 patients were enrolled in the study and subsequently randomised into one of two groups: the study group of ASCS combined with compression therapy, and a control group of standard compression alone. Patients in these groups were assessed in terms of the primary effectiveness endpoint— incidence of complete wound closure (45 out of 52 completed follow-up to week 14)—as well as donor site closure, pain, health-related quality of life, satisfaction, and safety.

The key results

Focusing on the results, Hayes et al write: “At week 14, VLUs treated with ASCS plus compression had a statistically greater decrease in ulcer area compared with the control [patients] (8.94cm2 vs.

1.23cm2, p=0.0143). This finding was largely driven by ulcers less than 10– 80cm2 in size, as these ulcers had a higher mean percentage of re-epithelialisation at 14 weeks (ASCS plus compression: 69.97%, control: 11.07%, p=0.0480).”

The authors continue, also revealing that subjects treated with ASCS plus compression experienced a statistically significant decrease in pain rating (p=0.017) and increase in all aspects of health-related quality of life, compared to patients in the control cohort. With respect to the latter, the authors detail that differences between the groups emerged

At week 14, venous leg ulcers treated with ASCS plus compression had a statistically greater decrease in ulcer area compared with the control.”

by four weeks and “reached statistical significance by eight weeks for cosmesis (p=0.0145) and 14 weeks for emotional well-being (p=0.0439)”.

Although there was no significant difference between the two cohorts in terms of patient satisfaction, it was noted the ACSC plus compression group had slightly higher satisfaction scores in both the subject and physician ratings for all wounds, while a similar percentage of patients in each group experienced adverse events (17 in ASCS plus compression group versus 16 in compression group). Infection rates were also similar, though “by week 14, four subjects in the compression only group had mild or moderate infection versus no observable infection in the treatment group”.

Hayes et al conclude, emphasising that “results from this study indicate that application of ASCS […] appears to be a safe and an effective approach for treatment of VLUs when combined with compression therapy, specifically for ulcers less than 10–80cm2 in area”.

“In addition to the healing potential, the reduction in pain and improvement in health-related quality of life may have implications on the overall reduction of costs associated with the treatment of VLUs regardless of ulcer size. Future work is warranted to study the effect of ASCS plus compression on wounds, evaluating the healing outcomes and impact that a decrease in wound size has on pain and the cost-effectiveness of the treatment.”

Issue 03 | June 2020

Wound care and COVID-19

How COVID-19 is changing wound care: New triage models, metabolic inflammation in diabetes, and the need for international consensus Continued from page 1

COVID patients coming into the hospital, filling up the ICU [intensive care unit], taking over the wards. At one point we had nearly 600 COVID patients in the hospital, and only one ward which was not COVID. Some of the staff from the foot clinic were redeployed.

“But, the NHS acted as a whole, and the mandate coming from the NHS actually said that multidisciplinary foot clinics should continue, so we did not have to close down completely.” Patients deemed “non-essential” (those with simple ulcers and mild infections) were treated in the community, rather than in the hospital, leading the multidisciplinary foot clinic team to conduct a reorganisation. Edmonds described how this created “a safety net of care” by linking up with the community podiatrists and community nurses.

“We feel that we have kept the standard of care to our patients, but on the other hand been able to reduce the number of patients coming into clinic by 30 to 40%”, he summarised.

Both Bell and Edmonds highlighted the importance of communication and coordination when treating a greater number of patients in the community as opposed to in outpatient clinics. Bell raised the concern that these disparate specialists, the nurses and podiatrists and diabeticians, may work in silos, but added that it sounded as though Edmonds’ experience in London was well-organised due to presence of a dedicated coordinator role to structure the new triage system.

Musing on the potential fallout from this stripped back outpatient service, Bell said: “I just think for the long-term, this is going to be something note-worthy.

How is it going to have a direct impact— will wound care centres ever be the same? It sounds like, in a sense, there is a recognition of the services we provide.

However, there might be a de-emphasis on the outpatient wound centre.”

“Among the weaknesses that have been revealed, I think across the board in every country, is the lack of a centralised plan to deal with a sudden need to react acutely, while still managing those chronic situations,” Li commented, weighing in on the discussion.

“I think one thing other specialities are going to teach us in wound care is the need to actually have a protocol for normal management, acute response management, and then how to triage those patients according to need, but also where do you send them, and what is the chain of communication that is required.”

A “telemedicine explosion has been fuelled by this pandemic”—What does this mean for the future of wound care?

“I have been a proponent of telemedicine for years,” Bell disclosed, “because I saw the value as smart phones and the technology emerged. Why would you not use a phone to communicate with your patients and vice versa?” Before the COVID-19 pandemic racked healthcare systems worldwide, Bell would ask his patients to send him a photo of their wound to keep him apprised of their symptoms between clinic visits and so he can guide them through any at-home behaviours or treatments.

Bell explained how he saw the rapid adoption of telemedicine as “one of the silver linings” of the current pandemic, calling telehealth “something we have needed for a really long time.

However, Li expounded on some of the challenges presented by telehealth.

“First of all,” he said, “there is a lot of heterogeneity in the comfort level of physicians and patients alike with technology, and some of our neediest patient populations do not necessarily have access to the kind of technologies that might be required to do reliable telemedicine.

“The second issue I think has to do with privacy. Many of these telemedicine consults occur in whatever space we are in. […] The other issue is actually control of time. If you schedule a tele-visit, I think that is appropriate, but it becomes really easy, without any control, to reach out to your provider at any time, which I think my patients might quite like, but clinicians might not be able to handle that as well. Finally, it is documentation— being able to do appropriate care on the fly using telemedicine. We need a structured approach to this—how do you appropriately document it [the care given], and then how do you actually share that documentation with other providers?”

The interrelationship between COVID-19 and diabetes

“The interrelationship between COVID and diabetes has really been a very dramatic one,” Edmonds explained.

The American College of wound healing and tissue repair released a position statement in April saying that the people most vulnerable to COVID-19 are the same demographic as those visiting wound care clinics. Referring to this, Ennis said: “So we knew right away that there was going to be a vulnerability piece. Are we going to be seeing wounds in a different way, or presenting in a different way?” he asked the discussants.

Li thought so, answering: “As somebody who specialises in the microcirculation, one of the things that I did was pull together my research team, and we began actually looking at tissues of people who had succumbed to COVID-19 and tried to understand what

had happened at the pathophysiological level.”

COVID-19 is a respiratory disease caused by a virus that is more closely related to the virus that causes the common cold than influenza, he explained. The novel coronavirus travels straight to the vascular endothelial cells lining the pulmonary vessels, targeting the gas-exchange network.

While inside the endothelium, the virus particles upregulate the ACE-2 (angiotensin-converting enzyme 2) receptor, which enables viral entry into the host cell. “So this is really an angio-centric disease as much as it is a respiratory disease,” Li clarified. The microvascular thrombosis triggered by the presence of the virus in the endothelial cells leads to the attempted immunological clearance of the virus in those areas, further damaging the vessel lining and causing additional clotting.

“That then brings us straight over to the wound,” Li said. If this is happening in a lower extremity in an elderly patient or a diabetic patient with an ischaemic ulcer, it will potentially make it harder for the tissue to granulate and heal.

“I think we have not even begun seeing some of the potential downstream problems from COVID-19 infection in our diabetic population,” Li surmised.

We have not even begun seeing some of the potential downstream problems from COVID-19 infection in our diabetic population. We [...] should unite and start to gather that data.”

“Since we know this might occur, we as a wound healing community, as clinicians, should unite and start to gather that data, so we can quickly get our arms around it the same way infectious disease doctors have tried to gather data from the respiratory side. Secondly, we should mobilise the research teams to take some of this tissue and look at it. So for example, if there is an amputation, whether it is a BK [below-the-knee] or AK [above-the-knee], we should take a look at that tissue and see if we can find any COVID correlates that may actually help us.”

Citing a research letter published 6 May in the Journal of the American College of Cardiology reporting that systemic anticoagulation may be associated with improved outcomes among patients hospitalised with COVID-19, Li asked: “Should we, as a wound care community, start to think in our patients who have chronic wounds, or might have chronic wounds, about some

5

form of adaptive anticoagulant treatment to be able to mitigate either the formation of wounds, improved healing of wounds, or prevent recidivism? These are all outstanding questions that I think we can start to think about now.”

Thinking about these downstream effects of SARS-CoV-2 infection, Bell wondered if wound care clinicians are going to start seeing previously healthy patients coming into the clinic with chronic ulceration or a certain type of wound following infection with COVID-19.

What is the new normal for wound care? Life after COVID-19

“As providers, we are the rate-limiting step,” Bell said, talking about the wound care treatment algorithm. “To me, I think one of the weak links in the wound care model is that we have so many top-notch providers, or people who look at wound care as a full time specialty. […] The old model that we have seen is not going to completely go away, but there are going to be some major adjustments to it.” He proposed that coordinating with home health or other formats of outpatient care will “become more the norm”.

He also raised the issue of payers, noting that in the future they may flag that wound care specialists had been able to treat their patients during the height of the COVID-19 pandemic despite a reduced number of visits to the wound centre, and that this limited model might be attractive to them. “I think there is going to be this de-emphasis on the services provided or the frequency that you will be able to go to an outpatient wound centre.”

Edmonds chimed in: “There already was a trend to increase resources in the community, […] and I think this pandemic will accelerate that.

“Treating the diabetic foot ulcer is very much a holistic pursuit,” he added. “You might say that the patient with the less severe ulcer has actually had improved care during this pandemic. They are being treated in the community, at home, and they can get in touch with us very quickly. […] I think that equilibrium and that dynamism will go on into the future, so I am optimistic, actually.”

Also concluding on an upbeat tone, Li said he thought that following this pandemic, wound care specialists would have an opportunity to develop a set of best practices on the international level for how to help prevent, treat, and manage people who are vulnerable in the wound care setting without a lot of “fancy equipment and exhibition halls”.

“I think if we could get some sort of international consensus on what that could be in the setting of what we are learning with COVID,” he continued, “then we would actually have an opportunity to reboot all the competitiveness and all the pettiness that surrounds wound care, and have a new starting point. […] There is a new opportunity for leadership to harmonise the practices that would allow wound care to become more recognised in its own right as a specialty.”

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June 2020 | Issue 03

Infection

No decrease in surgical infections for trauma patients treated with NPWT over standard dressing

Use of incisional negative pressure wound therapy (NPWT) does not change the rate of deep surgical site infection, for patients undergoing surgery for major traumarelated lower limb fractures, according to results of the WHIST randomised clinical trial. Published online in the Journal of the American Medical Association (JAMA), no significant difference was found when comparing patients treated with NPWT and a standard dressing.

M

atthew L Costa (University of Oxford, Oxford, UK) and colleagues write that the findings of the trial, which included 1,548 adults, “do not support the use of incisional NPWT for surgical wounds associated with lower-limb fractures from major trauma”, although they note that “the event rate at 30 days was lower than expected”.

According to the authors of WHIST, deep wound infection rates are “high” following surgeries on major trauma-related fractures.

“Treating these fractures is complicated by the systematic inflammatory response to major trauma, as well as the extensive soft tissue injuries adjacent to the broken bone which, taken together, may cause high rates of wound infection following surgery for lower-limb fractures after major trauma,” Costa et al explain.

There has been some Matthew L Costa

suggestion that new techniques for wound management, such as incisional NPWT, have potential for reducing the rate of infection, though the evidence for this profile of surgical patients is limited. “The aim of this randomised clinical trial,” write the authors, “was to determine if incisional negative pressure wound therapy was more effective than standard wound dressing in reducing the rate of deep surgical site infection in wounds associated with surgery for a fracture in the context of major trauma to the lower limb.”

The trial was conducted at 24 trauma hospitals in the UK between July 2016 and April 2018, with all of the 1,548 adults who participated in the study over the age of 16 years. Of these patients, 785 were randomised to receive incisional NPWT, while 763 received a standard wound dressing that did not involve negative pressure.

“The primary outcome measure was deep surgical site infection at 30 days, diagnosed according to the criteria from the US Centers for Disease Control and Prevention,” write Costa and colleagues. They add that a pre-planned secondary analysis of the primary outcome was performed at 90 days. Furthermore, secondary outcomes for WHIST included patient-reported disability, health-related quality of life, surgical scar assessment and chronic pain at three and six months, as well as other local wound healing complications at 30 days.

Of the 1,548 participants (mean age, 49.8 years; 38% women [n=583]) who were randomised, Costa et al report that 1,519 (98%) had data available for the primary outcome. “At 30 days, deep surgical site infection occurred in 5.8% (45 out of 770 patients) of the incisional negative pressure wound therapy group, and in 6.7% (50 out of 749 patients) of the standard wound dressing group (odds ratio, 0.87 [95% CI, 0.57–1.33]; absolute risk difference, -0.77% [95% CI, -3.19– 1.66%]; P=0.52)” they explain.

Additionally, there was no significant difference in the deep surgical site infection rate at 90 days; 11.4%

US podiatrists outline triage system and community care focus to combat COVID-19 Continued from page 2

Moving into the community

Although the American Podiatric Medical Association (APMA) strongly discourages hospitals and regulators from “declaring all ‘podiatric procedures’ as non-essential”, Rogers et al agree that “in some cases that are not critical, podiatrists can shift the site of hospital-based wound care and surgical procedures to ambulatory surgery centres and podiatry offices”.

“A large percentage of outpatient wound centres are located in the physical space of the hospital, which is unique among all outpatient service lines, for both billing reasons (hospitals charge facility fees) and safety considerations (ability to respond to hyperbaric oxygen treatment emergencies).

“However, in the coming months, we anticipate that many wound centres will close because of guidance from the US Surgeon General, CMS, and state/ local governments to reduce outpatient traffic in the hospital and non-essential

services,” write the authors, who also state that for some patients, who require revascularisation, referral to officebased labs—that are extensions of vascular surgery, cardiology, or radiology outpatient offices—is possible.

Another key aspect of the move away from hospital-based care is the increased employment of telemedicine and remote patient monitoring as modes of treatment.

“The CDC is recommending that providers leverage telemedicine whenever possible to protect patients and staff from COVID-19,” Rogers et al reveal, adding that “in our experience using FaceTime and Google Glass in wound-based assessment, combinations of ‘store and forward’ photos, short message service (SMS) text, or text video chat are useful to screen for infection and evaluate wound progress.”

Remote patient monitoring is said to show “great promise” too in identifying areas of impending injury/tissue loss, as well as the presence of potential infection, while monitoring through temperature

(72 out of 629 patients) in the NPWT group developed an infection, compared to 13.2% (78 of 590 patients) in the standard dressing group (odds ratio, 0.84 [95% CI, 0.59–1.19]; absolute risk difference, -1.76% [95% CI, -5.41–1.90%]; P=0.32). “For the five prespecified secondary outcomes reported, there were no significant differences at any time point,” continue the authors.

Highlighting some of the trial’s limitations, Costa et al comment: “First, because of the emergency nature of the surgery, it was anticipated that some patients who were randomised would subsequently be unable or unwilling to participate. However, the majority of patients (85%) agreed to participate. Second, 100 patients did not receive the randomised intervention. As expected, when testing a relatively new intervention such as incisional NPWT, the majority of the crossovers were from the incisional negative pressure wound therapy group to the standard wound dressing group (n = 92).”

Among patients who underwent surgery for major trauma-reated lower limb fractures, use of incisional negative pressure wound therapy [...] resulted in no significant difference in the rate of deep surgical site infection.”

Concluding, the authors state: “Among patients who underwent surgery for major trauma-related lower limb fractures, use of incisional negative pressure wound therapy, compared with standard wound dressing, resulted in no significant difference in the rate of deep surgical site infection. The findings do not support the use of incisional negative pressure wound therapy in this setting, although the event rate at 30 days was lower than expected.”

sensing devices is supported by “robust data” as an “early warning system for diabetic foot ulcers in high-risk patients”.

“These patients were typically seen in podiatry offices every two to six months for preventative visits to reassess changes and risk for ulceration,” explain the authors, “but with remote patient monitoring could be pushed out longer and the podiatrist notified when a problem is imminent.”

Visiting the home

It is expected by the APMA that use of home health will rapidly expand as a result of the COVID-19 pandemic.

According to the authors, as well as regular telemedicine check-ins from a

Podiatrists must mobilise to provide organised care of the diabetic at-risk foot in a shifting environment and system.”

provider, podiatrists can order home health visits, dressing changes, and/or prescribe dressings and antibiotics to be used at home by the patient.

Regarding the expansion of home health, the authors state: “All indications are that podiatrists will be seeing a reduced regular workload over the next 12 to 18 months, with cancellation of clinics and elective surgeries, increased patient no-show rate, and reduced demand for some foot and ankle care. There are opportunities for podiatrists to play a larger role in in-home care. House calls can be conducted with lower-extremity exams for infection and peripheral arterial disease and podiatrists can perform simple wound procedures in the home.” The risks that this can pose to both patient and provider would have to be managed with the use of personal protective equipment (PPE).

In closing, Rogers, Lavery, Joseph and Armstrong deliver a clear message to podiatrists in the USA, asserting the need to adapt in the wake of the coronavirus pandemic. “All hands are on deck preparing to treat the expected wave of COVID-19 patients. Podiatrists must mobilise to provide organised care of the diabetic at-risk foot in a shifting environment and system.”

Issue 03 | June 2020

Wound care and COVID-19

Alliance of Wound Care Stakeholders highlights importance of wound care amid COVID-19 pandemic In a statement from the Alliance of Wound Care Stakeholders, a multidisciplinary trade association of physician specialty societies and clinical and patient associations, it has been emphasised that wound care is an essential—not elective—service that prevents admissions to hospital among “a fragile cohort of patients at high risk of COVID-19”.

THE PANDEMIC PROMPTED hospitals and acute care facilities to change standard operating procedures in the USA in advance of the admission of infected patients As a result, services, procedures, and surgeries deemed “non-essential” have been shut down, “without thorough consideration of the ramifications” says the Alliance of Wound Care Stakeholders.

Outpatient-based wound care departments have been placed in the non-essential group by many hospitals.

The Alliance of Wound Care Stakeholders has expressed concern that this decision will result in unintended negative consequence and trigger a gradual influx of patients to the emergency department (ED).

Non-healing wounds, left untreated and unmanaged, can result in significant medical issues including infection, sepsis, the need for limb amputation, and even death. As a result, many procedures provided by wound clinics are considered to be essential, in order to protect the health of patients and prevent an escalation of their disease.

Individuals with chronic wounds commonly have other chronic conditions, such as type 2 diabetes,

hypertension, venous insufficiency, peripheral arterial disease, and/or chronic kidney disease. This cohort of fragile patients is high risk if they develop COVID-19, but are also high risk for increased morbidity and mortality if their access to wound care is abruptly discontinued.

Addressing the COVID-19 pandemic and the importance of avoiding unintended consequences for wound patients, the Alliance states: “Across the country, wound care providers are working to ensure that the health of our patients is protected during the COVID-19 crisis. We are adopting aggressive infection control and social distancing precautionary measures at our sites and with our staff.

“While wound care providers are working to limit clinic visits and move as many patients as practical to telehealth, office visits or home health follow-up where appropriate, wound clinics must be able to provide those urgently needed wound care procedures that are infection-sparing, limb-saving and life-saving. These procedures are essential, not ‘elective,’ and ultimately will reduce wound patients’ potential for needing other

Assessing the impact of coronavirus on wound care patients and practice William J Ennis Comment & Analysis With healthcare systems around the world facing the most severe global health crisis in a generation, wound care is one of many areas that could be seriously affected. As iWounds News editor-inchief William J Ennis explains, the commonality between wound patients and the population most at risk in the midst of COVID-19 will have major implications on the practice of wound care, requiring an increase in clinical efficiency and innovation.

I

was initially slated to discuss the outlook for wound care in 2020, but the emergence coronavirus has caused me to rethink my topic.

Last December, in Wuhan, China, an outbreak was initially reported: now, of course, cases have been confirmed on six continents and in more than 100 countries, and our healthcare systems and our daily lives have been signifcantly impacted by the pandemic.

Although COVID-19 is mild in most cases, the elderly and those with underlying comorbid conditions can have severe complications. The death rate is about 1.4% overall, however higher rates

are noted in the elderly. In many cases, those are our wound care patients! Once COVID-19 officially graduated from epidemic status to a pandemic, it was of the utmost urgency that we organised and prepared as our wound care patients became exposed.

In the USA, the majority of wound care clinics are located within hospital campus grounds. The government and local public health departments have begun to urge, and at times regulate, that all “non-essential” care be treated remotely or in offices away from the hospital. These are the times when the absence of a formal specialty status

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hospital services such as operative intervention or amputation, which require prolonged hospitalisation.”

The Alliance of Wound Care Stakeholders have made their stance clear, advising healthcare systems to “leave clinics open to manage complex wounds in clinically complex medical patients who are at risk for limb loss, hospital admission, amputation or infections”.

They continue: “Hospital administrations should take into consideration input from providers when making these decisions, and deploy appropriate triage criteria when reducing essential clinical services. Enabling continuity of care for these wound patients will improve outcomes while unburdening emergency departments, operating rooms, hospital staff and hospital beds for the COVID-19 crisis. Keeping these patients out of the ED and out of hospital beds can in turn limit exposures and curb COVID-19 infection among this fragile population.”

Finally, the Alliance has confirmed the creation of a task force to help wound clinics and health systems address the evolving realities of the COVID-19 pandemic while avoiding unintended consequences for wound patients.

Across the country, wound care providers are working to ensure that the health of our patients is protected during the COVID-19 crisis.”

truly hurts our patients and the field of wound care.

The impact of non-healing wounds has a profound impact, not only on the quality of our patients’ lives, but on the overall healthcare system. Here are a few facts: There are 6.7 million patients with non-healing wounds.

Approximately one in four patients with wounds receive care.

Patients treated with a visit cadence of once per week have higher healing rates.

Patients with wounds that do not receive care at a wound clinic are 20 times more likely to end up as an inpatient (2% if wound healed vs. 40% if not).

Hospitals that effectively discharge wound patients to wound clinics have 25% lower 30-day readmission rates Patients with effective wound care from high-performing clinics use 30% less acute care services. (Note: These are patients who are discharged home, which accounts for 40% of the patients; this is based on Healogics national data and Centers for Medicare & Medicaid Services public files.)

As we have described, this complex patient population already poses challenges for the healthcare system when it is running at its normal pace.

These patients will overwhelm already stressed acute care services if untreated.

At the same time, we need to recognise that hospital clinics can expose patients to potential risks as well. Therefore, the “standard of care” that we have developed for wound care clinics is going to change, now and likely into the future.

Staggered scheduling, restrictions of visitors, pre-visit phone calls for triaging, and the use of machine learning algorithms that help us stratify those patients at the highest risk—of hospitalisation, emergency visits, and non-healing—will be used to assist the provider in making these critical decisions. In addition, a more liberal adoption of telemedical support tools will become a more important resource in our arsenal of treatment options.

How we staff, manage, clean, and direct patient flow will be changed from here on. Clinical efficiency will become another “vital sign” measurement for grading the quality and effectiveness of our wound clinics. Healing rates will be matched with total cost of care, and the overall medical condition of our patients.

In every crisis, tragedy, or natural disaster, there are many sad new realities that emerge. Equally, times of crisis yield times of accelerated innovation.

We are all aware that our current clinic infrastructures are not patient-centric, and that we could do more to improve the patient experience, along with their clinical outcomes. If we band together and collectively improve the care we deliver, my original story of the future of wound care in 2020 will be a bright one indeed.

William J Ennis is president of the American College of Wound Healing and Tissue Repair and Catherine and Francis Burzik professor of surgery at the University of Illinois Hospital and Health Sciences System, Chicago, USA. Ennis is also chief medical officer at Healogics The author has no other disclosures relevant to this article.

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June 2020 | Issue 03

Interview

Profile

Thomas Serena

Thomas Serena is founder and medical director of The SerenaGroup, as well editorin-chief of iWounds News, and has conducted a number of clinical trials as leader of a research foundation. Speaking to iWounds News, Serena discusses new developments and research topics in the wound care space and explains how work is being done to “revolutionise the field of wound healing”.

Why did you decide to pursue a career in medicine and focus, in particular, on the area of wound care?

The technical, academic and physical challenges inherent in surgical practice inspired me to move on to a still more challenging, though less prestigious, general surgery residency and follow the path of the physicians who established the speciality. As a surgeon, I strove to achieve infection-free wound healing in all cases.

However, it became apparent that not all wounds heal as expected, and patients suffering from chronic wounds filled my waiting room. I found their cases intriguing: stories of decades old ulcers, caustic home remedies, and patients forced into reclusive lifestyles due to malodourous, weeping sores. I thought a solution must exist for this growing population of patients with nonhealing wounds but searching the literature provided little guidance: I found plenty of opinions but little or no evidence.

During your training, were there any key individuals who guided your journey and helped you to become who you are today?

David Steed, one of the pioneers in diabetic foot ulcer (DFU) clinical trials, encouraged my interest in clinical trials on wound healing in the late 1990s. Since that time, SerenaGroup and The SerenaGroup Research Foundation have conducted more than 100 clinical trials.

Our goal is to advance the science of wound healing and bring the specialty into mainstream medicine.

During your time in this arena of wound care and healing, what have been some of the most significant changes you have witnessed?

The speciality of wound care has progressed from a part-time hobby for physicians to a full-time practice.

Today, I am a full-time “woundologist”. The emergence of woundologists has led to a proliferation of advanced wound care centres, while the increased awareness of, and attention towards, patients with chronic wounds has created an industry. As a result, the wound care clinician of today has hundreds of products at his or her disposal to treat chronic ulcers.

What prompted you to enter the field of research in the wound care space and how is the SerenaGroup working to improve practice across centres in the USA? Cooperative groups have successfully promoted and supported clinical trials in most fields of medicine. The SerenaGroup Research Foundation (SGRF) began with a nexus of centres under the direction of a wound care management group and, as part of its work, the group has trained many study coordinators and investigators.

In 2019, SGRF completed or launched several clinical trials, studying such innovations as cellular or tissuebased products for wound care (CTPs) and topical oxygen in diabetic foot ulcers. A venous leg ulcer study evaluating the efficacy of a Beta-glucan medication is nearing completion, while an investigation of a

novel oral medication for venous disease completed enrolment in November 2019. In addition, early phase trials examining the efficacy of genetically modified tissues and light therapy were completed in 2019.

The dedicated efforts of SGRF investigators have also led to the development of unique trial designs for diabetic foot ulcer studies on diagnostics and standardisation. In addition, creating study designs that garner reimbursement is a major achievement of the cooperative.

Have you encountered any difficulties conducting research in the area of wound healing and research?

Despite its successes, SGRF faces challenges. There is a need for investigator and coordinator education, most wound care centres have little research experience and wound healing trials differ from clinical trials in other fields. Funding also remains an obstacle in this field, but

The speciality of wound care has progressed from a part-time hobby for physicians to a full-time practice. Today, I am a full-time ‘woundologist’.

The emergence of woundologists has led to a proliferation of advanced wound care centres.” the foundation does plan to focus on avenues to improve funding for clinical research. The development of a cooperative group in the field of wound care has shown promise in enrolling patients in studies, supporting investigators and introducing wound centres to clinical research.

Do you agree that there has been a plateau in dressing technology with a need emerging for more advanced and innovative wound healing techniques?

In the late 20th century, moist wound healing was stateof-the-art in wound care. The 21st century, however, witnessed an explosion of dressings designed to support wound healing. Advanced therapies that accelerate healing—such as cellular and/or tissue products (CTPs)—followed. However, the specialty skipped a crucial step: there are no diagnostics to guide clinicians on the choice of dressing and advanced modalities. The advent of point-of-care diagnostics for bacterial burden and proteases will revolutionise the field of wound healing and lead to the development of new products and combinations of products.

Has there been a recent study or paper on an aspect of wound care and healing that stands out to you, and why?

SGRF conducted two randomised controlled clinical trials between 2018 and 2019, evaluating the use of fluorescence imaging (MolecuLight) in detecting moderate-to-heavy bacterial burden in chronic wounds.

The second RCT enrolled more than 350 patients and demonstrated that the fluorescent camera can detect bacteria with a high degree of accuracy and reproducibility.

Are there any other studies that the SerenaGroup has been leading in recent years?

The foundation also conducted several clinical trials on bacterial protease activity (BPA) as a biomarker for infection in acute and chronic wounds. The result of this research has led to a commercially available point-ofcare diagnostic for wound infection (WoundCheck).

The research started with the development of a technique to collect proteases from the wound bed.

After months of investigation, a reproducible and reliable technique was established. The next step was to compare the biomarker to quantitative tissue biopsies.

The foundation’s cooperative group conducted two

Issue 03 | June 2020

Interview

9

Fact File

Qualifications:

1996 MD, School of Medicine, Penn State University, Hershey, USA 1986–1991 Residency, Department of Surgery, Hershey Medical Center, Hershey, USA 1991–1992 Residency, SIU School of Medicine, Department of Surgery, Division of Plastic & Reconstructive Surgery, Springfield, USA

Academic Appointments (selected):

1995–2010 Assistant professor, lecturer and research coordinator, Physician Assistant Department, Gannon University, Erie, USA 2004–Present Faculty, Angiogenesis Foundation, Cambridge, USA

Professional Appointments (selected):

RCTs, which demonstrated that the bedside diagnostic accurately detects infection. In addition, the diagnostic improved the clinician’s ability to make the diagnosis of infection. Prior to clearing the test, the US Food and Drug Administration (FDA) requested a trial examining the impact of the test on wound healing outcomes. The foundation responded with a large multicentre clinical trial demonstrating that wounds positive for bacterial protease activity (BPA) healed significantly slower than BPA-negative wounds. In fact, the presence of BPA at the time of enrolment was a strong predictor of healing at 12 weeks independent of treatment regimen.

This outcome-based trial also found that diabetic foot ulcers testing positive for bisphenol A (BPA) were five times more likely to undergo amputation.

We have incorporated the fluorescence imaging and protease activity into our clinical trials with the goal of eliminating indiscriminate antibiotic and antiseptic use.

Can you recall any wound cases you have either seen or treated that were especially memorable?

My career has been marked by the challenging wounds that present to our clinics in the USA. However, caring for patients suffering from wounds following natural disasters, and in resource-poor countries, has left indelible memories. The makeshift wound clinic on the tarmac of the Port-au-Prince airport in Haiti after the earthquake in 2010, challenged all my wound care skills as well as highlighting the need for an interprofessional team. I have also taught wound care to clinicians and treated patients in Cambodia, Vietnam, India and East Africa. Saint Francis said: It is in giving that we receive; nowhere is this truer than in the resource-poor part of the world.

Away from wound care, in what way has your history as an All American gymnast impacted upon your life, and do you have any other hobbies and interests?

Gymnastics takes focus and persistence: it has prepared me for the peaks and troughs of wound care practice and research. At the moment, I love to read, travel and run.

1992–2002 General and vascular surgery, Warren Surgeons, Warren, USA 1997–Present Founder and medical director, The SerenaGroup Wound and Hyperbaric Centers, Cambridge, USA 2011–Present Founder and scientific director, The SerenaGroup Cooperative Group, Cambridge, USA 2018–Present Founder and medical director, The SerenaGroup Research Foundation, Cambridge, USA

Offices (selected):

2015 – 2016 President, American Professional Wound Care Association (APWCA).

2009 – 2017 Vice-President, American College of Hyperbaric Medicine.

2011–2016 Chair, Steering committee, Health Volunteers Overseas/ AAWC Global Volunteers 2018–Present Member, Planning committee for 2024 World Union of Wound Healing Societies (WUWHS) 2019–Present Board International Surgical Wound Complication Advisory Panel (ISWCAP)

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June 2020 | Issue 03

Venous stenting and insufficiency

Deep venous stenting presents advantage over ablation in achieving better ulcer healing rates “Venous leg ulcers (VLUs) secondary to deep venous stenosis represent a distinct class of patients who require a unique treatment paradigm,” stated Abhisekh Mohapatra (University of Pittsburgh Medical Center, Pittsburgh, USA), presenting results of a multicentre retrospective study of patients presenting with VLUs—between 2013 and 2017—that favoured deep venous stenting over ablation techniques.

SPEAKING TO ATTENDEES at the annual meeting of the American Venous Forum (AVF 2020; 3–6 March, Amelia Island, USA), Mohapatra begun his talk by noting that venous leg ulceration can arise from the individual incidence of deep, superficial, or perforator vein disease, or a combination thereof.

Regarding potential treatment options, the presenter commented: “Compression is the mainstay of therapy in all of these patients and is always important, regardless of the other interventions performed. When deep venous stenting is performed, it can significantly improve venous hypertension in the leg and aid in wound healing for these patients.

“However, multiple problems often exist, and in this

situation it is not clear which veins should be treated first.”

The aim of the study, which included data for 832 patients across 11 centres in the USA, was not only to determine whether the presence of deep venous stenosis affects the wound healing trajectory of VLU patients, but also to understand which treatment strategies affect ulcer healing in those diagnosed with deep venous stenosis.

According to Mohapatra, investigators focused their attention on the cohort of patients with deep venous stenosis; baseline characteristics, anatomy of venous disease and wounds, treatments performed, and wound healing trajectories, were all studied. Furthermore, the primary outcome was successful healing of the largest index ulcer.

Of the 832 patients in the dataset, 16.1% (n=134) had stenosis in the deep venous system. The demographics of these patients showed that those with deep venous stenosis, compared to patients without, were more likely to have a history of deep venous thrombosis (47% vs.

23.6%; p<0.001), have a hypercoagulable state (27.6% vs. 10.7%; P < .001), and be receiving anticoagulation (71.6% vs 25.5%; p<0.001). Moreover, patients with deep venous stenosis were more likely, on average, to have multiple ulcers (20.2% vs 9.9%; p=0.002).

Mohapatra added that all patients with deep venous stenosis had concomitant superficial vein reflux, while 26.1% (n=35) had refluxing perforator veins. Out of the 134 deep venous stenosis patients, stenting was performed in 70.9% (n=95), truncal ablation in 44.8% (n=60) and perforator ablation in 20.9% (n=28); when both stenting and truncal ablation were performed, stenting was undertaken first in 53.5% of cases.

Turning his attention to wound healing, the speaker revealed that patients who underwent deep venous stenting healed faster than those with untreated deep venous stenosis (hazard ratio 2.46; 95% CI, 1.49̵​̵-4.06; p<0.001). He also pointed to a multivariate model,

Chronic venous insufficiency identified as a leading cause of lower extremity lymphoedema A retrospective analysis of patients diagnosed with lower extremity lymphoedema, and treated in a cancer-affiliated physical therapy department, has found that chronic venous insufficiency (or phlebolymphoedema) is the “predominant cause of lower extremity lymphoedema”. Published online in the Journal of Vascular Surgery: Venous and Lymphatic Disorders, it was also revealed that one in four patients studied had more than one cause of lymphoedema.

“A

lthough malignant disease is ubiquitously documented as the dominant cause of lower extremity lymphoedema, our study challenges this doctrine by finding chronic venous insufficiency the prevailing cause,” write first author Steven M Dean (Wexner Medical Center, The Ohio State University, Columbus, USA) and colleagues.

According to the authors, “lower extremity lymphoedema is frequently encountered in the vascular clinic”. They explain that cancer is understood to be the most common cause of this condition in Western countries, with chronic venous sufficiency “overlooked” as a possible factor as to why lower extremity lymphoedema develops. “Moreover,

lymphoedema is typically ascribed to a single cause, yet multiple causes can coexist,” Dean et al add.

Citing the “dearth of definitive studies” comparing the frequency and importance of clinical characteristics of the most frequent causes, the investigators state: “The purpose of this study was to retrospectively document the prevalence and manifestations of the four most commonly encountered causes of lower extremity lymphoedema in 440 patients who presented to an oncology-affiliated physical therapy lymphoedema centre”.

A three-year retrospective chart review was conducted from January 2012 to December 2015, including patients with lower extremity lymphoedema who underwent complex decongestive

which showed that deep venous stenting is the only treatment modality studied in this review that actually improved wound healing (hazard ratio 2.48, 95% CI, 1.46-4.24; p=0.001).

“There are some limitations to this type of study, which largely reflect the data source that we used. As this was a large, multicentre database, collecting data from multiple sites often requires limiting the number of variables that are collected to limit the burden of data entry, so there is some lack of granularity with respect to these patients,” Mohapatra acknowledged.

He continued: “One of the things we wanted to know, but could not from the dataset, was whether the deep veins that were stenotic or restented were femoral or iliac veins, or the inferior vena cava. There are also

When deep venous stenting is performed, it can significantly improve venous hypertension in the leg and aid in wound healing .” different practice patterns at different institutions regarding how deep vein stenosis is diagnosed. Finally, it is unclear in some of the patients included why deep vein stenosis was diagnosed but not treated.”

Concluding, Mohapatra confirmed that stenting improved wound healing rates, whereas ablation of pathologic superficial or perforator veins did not.

Looking ahead, he posited that routine imaging of the iliocaval segment may help the clinician to pursue early deep vein stenting to maximise ulcer healing and avoid unhelpful truncal and perforator interventions.

lymphatic physiotherapy (n=524). A to be white (78.9%; p<0.0001), to proportion of patients (n=84) were demonstrate bilateral distribution (74.5%; excluded from the final analysis, note p<0.0001), and to have involvement of Dean et al, due to an infrequent or rare the left leg (bilateral, 69.1% [p<0.0001]; cause of lymphoedema, inadequate data unilateral, 58.9% [p=0.0588])”. Morbid to definitively substantiate the principal obesity was also considered to be “nearly cause, and the presence of secondary universal” (mean weight and body causes or associated clinical variables. mass index, 115.8 kg and 40.2 kg/m2, “After exclusion, 440 eligible patients respectively) among the cohort studied. were initially divided into […] four Dean et al conclude: “Although principal diagnostic categories, lymphoedema is typically reflecting the predominant ascribed to a single cause, cause of leg swelling,” we identified heterogeneous the authors detail. These causation in one in four categories included chronic patients. Chronic venous venous insufficiency causing insufficiency was the entity lymphoedema, cancer-related most likely to complicate lymphoedema, primary pre-existing lymphoedema lymphoedema, and lipoedema and was especially prevalent with lymphoedema.

Steven M Dean in cases of lipoedema and, Dean and colleagues unexpectedly, primary continue: “Patients within each of lymphoedema. Morbid obesity was the four principal diagnoses were pervasive and correlated with a analysed by demographic and baseline higher lymphoedema stage, and likely characteristics including age, sex, the predisposition to bilateral limb ethnicity, weight, body mass index involvement.

(BMI), and anatomic distribution.”

“Other notable findings included the The investigators underline that predilection for left leg involvement, chronic venous insufficiency was the female sex proclivity, and confirmation most common cause of the condition, of cellulitis susceptibility, which affected as demonstrated in 41.8% of the cohort. half of the chronic venous insufficiency Cancer-related lymphoedema followed and primary lymphoedema subsets. Total (33.9%), with primary lymphoedema knee arthroplasty was the most common (12.5%) third and lipoedema with cause of non-cancer surgery-mediated secondary lymphoedema (11.8%) fourth. worsening of pre-existing lymphoedema.

Other findings of the analysis showed An unexpected finding was the higher that “the collective cohort was more proportion of black patients in the likely to be female (71.1%; p<0.0001), primary lymphoedema cohort.”

Issue 03 | June 2020

Charcot foot

Understanding what it means to be “Charcot foot health literate” Benjamin Bullen Comment & Analysis Described as a “Cinderella condition”, Charcot foot is little understood by non-specialists. Benjamin Bullen presents a multidimensional conceptualisation of health literacy and underlines the importance of developing knowledge on the subject of Charcot foot.

EARLY CONCEPTUALISATIONS of health literacy focused on “the ability to read and comprehend written medical information and instructions”.1 Since the turn of the century, research has consistently reported that these “functional” health literacy traits may be lower among individuals with diabetes mellitus.2-4 However, a seminal paper by Don Nutbeam in 2000, “Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century,” described a continuum of escalating “functional”, “interactive” and “critical” health literacy traits.5 In addition to applied literacy skills, interactive (more commonly referred to now as “communicative”) health literacy further considers health-informationseeking behaviours.6 Such skills are necessary for individuals to make sense of information from a variety of increasingly online sources.7-9 Communicative health literacy skills are further necessary for engagement with health care professionals and the development of effective diabetes self-management behaviours.

Information appraisal represents more advanced “critical” health literacy skills, defined by Sara Rubinelli and colleagues10 as the “capacity to contextualise health knowledge for his or her own good health [and] to decide on a certain action after a full appraisal of what that specific action means for them ‘in their own world’.”

For people with diabetic peripheral neuropathy who are “At-risk” of Charcot foot development, further disease-specific contextualisation is warranted.

If you have never heard of Charcot foot, you are not alone. This rare yet potentially devastating condition has been defined as “a syndrome in patients who have neuropathy or loss of sensation”, and “includes fractures and dislocations of bones and joints that occur with minimal or no known trauma.”11 Classic signs of ‘Active’ disease are a unilateral, erythematous, hot, and swollen foot.

Moreover, sensory neuropathy may mask

painful symptoms and delay presentation to specialist services and timely belowknee offloading. Incidence has been reported among 0.1% and 29% of people with diabetes, while published prevalence ranges from 0.08–13%.12-14 Due to its relative rarity, Susan Freeman says “the Charcot foot is often the Cinderella of diabetic foot disease, requiring a high index of suspicion. Early referral and treatment is usually the key to prevent long term deformity and recurrent foot problems.”15 At the 20th Annual National Conference of The Diabetic Foot Journal, William Jeffcoate expanded on this metaphor in his presentation, entitled “The little we know about the Charcot foot, the Cinderella of Cinderellas: It is bizarre that the profession pays so little attention to such a serious condition”.16 We are aware of only one study investigating Charcot foot knowledge among health care professionals. Brian Schmidt and colleagues17 explored Charcot foot knowledge among 400 non-specialist US physicians, reporting poor or no practical knowledge among 68% of these individuals. Research among diabetes populations, including “At-risk” groups with diabetic peripheral neuropathy, are currently lacking.

Charcot foot health literacy may be defined as knowledge and understanding of the Charcot foot and having the skills and confidence to recognise “danger signs” and seek professional help.

“Danger signs” include the presence of an erythematous, hot and swollen foot in an individual with diabetic peripheral neuropathy. Within the UK, “professional help” may be multidisciplinary, including podiatrists and medical specialists.

Orthopaedic surgeons may also correct resultant foot deformity following resolution of the “Active” phase.

We wish to reiterate the need for a high index of suspicion of Charcot foot in the event of “danger signs”. To this end, all healthcare providers engaged with “Atrisk” populations should be Charcot foot

health literate.

Addressing practitioner literacy is just one piece of the puzzle, however. Recent UK and European research, involving 600 general practitioners and 1,188 cases of diabetes foot ulceration, reported that patient concerns prompted diagnosis in an average of 60% of cases.18 Further observational research is therefore warranted concerning the specific Charcot foot health literacy characteristics of patients. We urge the reader to discuss this condition with all “At-risk” patients, a sentiment shared by podiatry respondents to a recent Scottish survey.19-20 References: 1. Coulter A, Ellins J. Patient-focused interventions: a review of the evidence. Health Foundation London; 2006.

2. Schillinger D, Grumbach K, Piette J, Wang F, Osmond D, Daher C, et al. Association of health literacy with diabetes outcomes. JAMA. 2002;288(4):475-82.

3. Rothman RL, Malone R, Bryant B, Wolfe C, Padgett P, DeWalt DA, et al. The spoken knowledge in low literacy in diabetes scale. Diabetes Educ. 2005;31(2):215-24.

4. Cavanaugh K, Huizinga MM, Wallston KA, Gebretsadik T, Shintani A, Davis D, et al. Association of numeracy and diabetes control. Ann Intern Med. 2008 May 20;148(10):737-46.

5. Nutbeam D. Health literacy as a public health goal: a challenge for contemporary health education and communication strategies into the 21st century. Health Promot Internation. 2000;15(3):259-67.

6. Longo DR, Schubert SL, Wright BA, LeMaster J, Williams CD, Clore JN. Health information seeking, receipt, and use in diabetes self-management. Ann Fam Med. 2010;8(4):334-40.

7. Moreland J, French T, Cumming GP. Exploring Online Health Information Seeking in Scotland. PAHI; 2015.

8. Moreland J, French TL, Cumming GP. The Prevalence of Online Health Information Seeking Among Patients in Scotland: A Cross-Sectional Exploratory Study.

JMIR Res Protoc. 2015 Jul 15;4(3): e85.

9. Vandenbosch J, Van den Broucke S, Schinckus L, Schwarz P, Doyle G, Pelikan J, et al. The impact of health literacy on diabetes self-management education. Health Educ J. 2018;77(3):349-62.

10. Rubinelli S, Schulz PJ, Nakamoto K. Health literacy beyond knowledge and behaviour: Letting the patient be a patient. Int J Public Health. 2009;54(5):307-11.

11. Charcot arthropathy [Internet].; 2017 [cited 09/02/2020]. Available from: http://www.aofas.org/ footcaremd/conditions/diabetic-foot/Pages/CharcotArthropathy.aspx.

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12. Fabrin J, Larsen K, Holstein PE. Long-term follow-up in diabetic Charcot feet with spontaneous onset.

Diabetes Care. 2000 Jun;23(6):796-800.

13. Lavery LA, Armstrong DG, Wunderlich RP, Tredwell J, Boulton AJ. Diabetic foot syndrome: evaluating the prevalence and incidence of foot pathology in Mexican Americans and non-Hispanic whites from a diabetes disease management cohort. Diabetes Care.

2003 May;26(5):1435-8.

14. Frykberg RG, Belczyk R. Epidemiology of the Charcot foot. Clin Podiatr Med Surg. 2008;25(1):17-28.

15. Charcot foot [Internet].; 2015 [updated April 14; cited 09/02/2020]. Available from: https://www. glycosmedia.com/charcot-foot/.

16. Jeffcoate W. The little we know about the Charcot foot, the Cinderella of Cinderellas: It is bizarre that the profession pays so little attention to such a serious condition. 20th Annual National Conference of The Diabetic Foot Journal. Ibis Hotel Earls Court, London; 2019.

17. Schmidt BM, Wrobel JS, Holmes CM. Physician knowledge of a rare foot condition–influence of diabetic patient population on self-described knowledge and treatment. Clinical Diabetes and Endocrinology. 2017;3(1):2.

18. Manu C, Lacopi E, Bouillet B, Vouillarmet J, Ahluwalia R, Lüdemann C, et al. Delayed referral of patients with diabetic foot ulcers across Europe: patterns between primary care and specialised units. J Wound Care. 2018;27(3):186-92.

19. Bullen B, Young M, McArdle C, Ellis M. Charcot neuroarthropathy patient education among podiatrists in Scotland: a modified Delphi approach. Journal of Foot and Ankle Research. 2018;11(1):54.

20. Bullen B, Young M, McArdle C, Ellis M. It’s time we talked about Charcot foot: results of a podiatry patient education questionnaire. The Diabetic Foot Journal. 2019;22(3):12-7.

Benjamin Bullen is a podiatrist and lecturer in podiatry at Cardiff Metropolitan University, Cardiff, UK. He is undergoing professional doctorate research at Queen Margaret University, Edinburgh, UK. Co-authors: Matthew Young, consultant physician, NHS Lothian Diabetes Foot Service, New Royal Infirmary of Edinburgh, Edinburgh, UK; Carla McArdle, lecturer in podiatry, Queen Margaret University, Edinburgh, UK; and Mairghread Ellis, senior lecturer in podiatry, Queen Margaret University, Edinburgh, UK.

ACS releases triage guidance for wound care procedures during COVID-19 pandemic The American College of Surgeons (ACS) has announced the release of new clinical guidance for surgeons to curtail recommendations for elective surgical procedures, with the aim of preserving necessary resources for the care of critically ill patients during the COVID-19 pandemic.

“COVID-19: Elective Case Triage Guidelines for Surgical Care” is a new surgical triage document that was developed following expert review in several specialties and provides trusted information from the most current, best evidence available in a number of surgical fields, including vascular surgery and the treatment of wounds.

A range of procedures for the treatment of wounds have been graded from 1 to 3, depending on whether they should be postponed or not. No procedures related to wounds, gangrene or amputation have been deemed grade 1, which are those that should be postponed, Grade 2 procedures are divided into those which specialists should consider postponing (2a), and those which should be postponed if possible (2b). In the case of wounds, 2b procedures include: the treatment of wounds requiring skin grafts; amputation of toes for infection or necrosis; and deep debridement of surgical wound infection or necrosis Grade 3 procedures should not be postponed, and the ACS has decided that amputation of non-salvageable limbs due to lower extremity disease, and amputations for infection or necrosis (transmetatarsal, below knee, above knee), are the only exceptions listed under this category with regards to wounds.

According to a statement, these triage recommendations should be used in conjunction with a joint statement ACS has developed with the American Society of Anaesthesiologists (ASA) and the Association of Perioperative Registered Nurses (AORN), recommending medical centres to develop a Surgical Review Committee to act as an administrative body, providing defined, transparent, and responsive oversight for triaging surgical cases during the COVID-19 pandemic.

Moreover, the ACS, ASA, and AORN recommend decisions of the Surgical Review Committee regarding surgical cases be made on a daily basis, no later than the day before an operation, and should include a multidisciplinary leadership team representing surgery, anaesthesiology, and nursing.

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June 2020 | Issue 03

Chronic wounds

Five-year review of Singapore primary care system demonstrates rising impact of chronic wounds A five-year institutional population health review has revealed that there is a rising trend in the clinical and economic burden of wound care in the Tropics. Published in the International Wound Journal (IWJ), the study was conducted after two systematic reviews found just one investigation into the social and economic burden of chronic wounds on a population based in the Tropics, out of a total 47 identified.

CONDUCTED BY INVESTIGATORS in Singapore, the aim of the study was to evaluate the burden of wound care in a Tropic location. Writing in IWJ, first author Zhiwen J Lo (Tan Tock Seng Hospital, Singapore) and colleagues explain that data was examined from January 2013 to December 2017 at a university tertiary hospital and its affiliated primary care system of six polyclinics. “Within our data analysis, wounds were broadly classified into neuroischaemic ulcers, venous leg ulcers, pressure injuries, and surgical site infections,” they add.

Some patients were excluded from the study, such as those under the age of 21 years and patients with wounds not verified by eWounds. “Variables evaluated,” continue the authors, “include demographic details (gender, age, and ethnicity), clinical variables (Charlson Comorbidity Index [CCI] and Frailty Index), and healthcare administration and economic variables (length of stay, healthcare visit episodes, and healthcare costs).”

With CCI, “a method of categorising comorbidities of patients based on International Classification of Diseases (ICD) diagnosis codes”, each comorbidity category has an associated weight of 1–⁠6, according to the adjusted

Prediction model for healing of chronic wounds can “inform clinical decisionmaking” Investigators at the University of Southern California, Los Angeles, USA, have developed a severity adjustment model for predicting the healing trajectory of chronic wounds within 12 weeks. The research, published online ahead of print in Advances in Wound Care, affirmed that this model “can become the basis for applications like quality measure development, research into clinical practice and performance-based payment”.

“CHRONIC WOUNDS REPRESENT a highly prevalent but little recognised condition with substantial implications for patients and payers,” emphasise authors Sang Kyu Cho, Soeren Mattke et al, who argue that, despite

risk of mortality or resource use, which can be compiled to predict both surgical mortality and long-term survival.

Furthermore, the Frailty Index can be used to measure the health status of older individuals.

Concerning the study’s results, Lo et al emphasise a number of key findings: “Between 2013 and 2017,

A multidisciplinary and institutional strategy must be adopted to reduce this clinical and economic burden.” there were a total of 56,583 wound-related inpatient admissions for 41,461 patients, with a 95.1% increase in wound episodes (142 and 277 wound episodes per 1,000 inpatient admissions in 2013 and 2017, respectively).

“In 2017, the average length of stay for each wound episode was 17.7 days, which was 2.4 times that of an average acute admission among the 12,218 patients

the development of improved wound care products and advanced treatment modalities, more consistency is required in how these methods are used in practice.

However, “predicting healing rates of chronic wounds and comparing to actual rates could be used to detect and reward better quality of care,” they hypothesise.

Although a number of severity adjustment models have been developed, the authors note that many of these are limited due to relying on a small sample size, applicability to just one type of wound, and low prediction accuracy.

They also acknowledge that more recent studies have “leveraged electronic medical records (EMRs) and machine learning techniques to improve prediction accuracy”, though the usability of these data is limited too.

Outlining their aims, Cho, Mattke et al write: “The objective of our study is to develop and validate a unified severity adjustment model for a broad range of chronic wounds that can form the basis for a quality measure, as it is entirely based on routinely collected data from intake visits at wound care clinics.”

In order to build this model, the investigators analysed EMR data for 620,356 chronic wounds of various aetiologies, accounting for 261,398 patients across 532 wound care clinics in the USA. Moreover, “patient-level and wound-level parameters influencing wound healing were identified from prior research and clinician input”, in addition to the development of logistic regression and classification tree models to predict the probability of wound healing within

with 16,674 wound episodes in 2017, [and] 71.5% were more than 65 years of age with an average Charlson Comorbidity Index of 7.2.”

Investigators also underlined that within the healthcare cluster studied, gross healthcare costs for all inpatient wound episodes totalled USD$216 million within hospital care and $596,000 within primary care, while the average gross charge per wound episode was $12,967.

The breakdown of different wound types, and their clinical and economic burden, showed that in 2017, pressure injuries accounted for the largest number of inpatient episodes (n=4,981), followed in succession by surgical site infections (n=2,463), neuroischaemic ulcers (n=949) and venous leg ulcers (n=112). In terms of average stay, pressure injuries were once again the highest (18.6), followed by neuroischaemic ulcers (15.8), surgical site infections (14.9) and venous leg ulcers (13).

Results for clinical variables demonstrate that venous leg ulcers had the lowest CCI in 2017, at 5.2, compared to surgical site infections (5.9), pressure injuries (8.3) and neuroischaemic ulcers (8.4). Neuroischaemic ulcers were also found to affect the frailest patients, according to the Frailty Index.

The authors conclude that “similar to global data, there is a significant and rising trend in the clinical and economic burden of wound care in the Tropics.” In 2017, over 25% of inpatient admissions had woundrelated issues, with the average length of stay 2.4 times that of an average tertiary hospital admission.

“These patients are elderly,” Lo and colleagues continue, “with multiple comorbidities and are frail.

A multi-disciplinary and institutional strategy must be adopted to reduce this clinical and economic burden, such that benefits on a tripartite front, for patients, clinicians, and healthcare systems, may be achieved.”

Soeren Mattke

12 weeks, “using a random sample of 70% of the wounds and validated in the remaining data”.

Of the wounds included in the analysis, 58.9% (n=365,659) were healed by week 12. Explaining the results, Cho, Mattke et al write: “Because of the large sample size, all variables, except for patients’ history of diabetes and chronic obstructive pulmonary disease, showed statistically significant differences, even when the absolute magnitude of the differences was small.”

Regarding usefulness, the authors

reveal that the accuracy of a prediction model using only demographic variables was limited, with an area under the curve of 0.556, which only rose to 0.605 with the addition of indicators for comorbid conditions. On the other hand, “addition of variables capturing wound characteristics resulted in substantial improvement in predictive accuracy, with an area under the curve of 0.712”.

The study, although based on a large dataset, was limited, mainly because it only looked at data from one wound care system and would have to be validated with data from other settings. Also, these data were collected under real-world conditions, “without validation and/or formal assessment of coding quality,” and could be subject to measurement error.

“Our findings show that wound healing can be predicted based on realworld data from EMRs and a model based on prior evidence and clinical reasoning. Our model can inform clinical decision-making and form the basis for applications like quality measure development, future research into clinical practice to determine sources of variability, and performance-based payment,” the authors conclude.

Our findings show that wound healing can be predicted based on real-world data from EMRs and a model based on prior evidence and clinical reasoning.”

Issue 03 | June 2020

Market watch

platform for faster and more accurate digital wound measurement

Product News

PICO 14

Smith+Nephew launches upgraded NPWT system for use on high-risk surgical patients

Smith+Nephew has announced the US launch of the new PICO 14 single-use negative pressure wound therapy system (sNPWT), which has a pump duration of up to 14 days. According to a statement, the new pump builds on the features and advantages of previous PICO sNPWT variants, and comes with an enhanced pump which requires less user intervention.

Fourteen days of therapy may be particularly relevant for patients where both the risk of surgical site complications and the consequence of obtaining them are high, such as cardiothoracic surgery and abdominal surgery.

Complications following coronary artery bypass graft surgery (CABG) can devastate patient lives, with up to a 35% in-hospital mortality rate associated with deep sternal wound infections and mediastinitis, and length of stay as long as 23 days per patient, which incurs substantial healthcare associated costs.

Following colorectal surgery, the consequences to the patient and healthcare system of a surgical site infection (SSI) have a similar impact, with hospital lengths of stay as high as 28 days in a surgery speciality that also has one of the highest incidences of SSI rates of up to 28%.

In one study, prophylactic use of PICO sNPWT significantly reduced the incidence of wound complications by 70% following coronary artery bypass graph surgery, compared with standard dressings. In a study of elective and emergency abdominal surgery PICO sNPWT demonstrated a 74% reduction in surgical site infection rate at 30 days postoperatively, again compared to standard dressings.

The risk of developing a postoperative wound complication depends on the type of surgery and patient risk factors. The presence of just one major risk factor, such as a BMI higher than 40, or uncontrolled diabetes mellitus, or two or more moderate risk factors, like advanced age and smoking, places patients at high risk of surgical site complications.

The PICO sNPWT dressing includes a proprietary AIRLOCK layer that uniformly and consistently delivers sufficient NPWT across a surgical incision and the surrounding zone of injury.

This unique feature is designed to help reduce the risk of wound complications by reducing postoperative fluid and tension around a closed surgical incision, when compared with standard dressings.

The combination of these actions helps reduce the risk of surgical wound dehiscence and SSIs, the two most common surgical site complications.

Aurealis Therapeutics reveals first use of biologic drug AUP-16 for chronic wounds

Aurealis Therapeutics has announced that the first diabetic foot ulcer (DFU) patient has been dosed with AUP-16, its three-in-one combination biologic drug for chronic non-healing wounds and regenerative diseases. The trial, currently being performed in nonhealing DFU patients, is designed to evaluate the safety, tolerability and preliminary efficacy of a repeated, doseescalating administration of AUP-16.

According to a statement, the primary objective of the trial is to determine the safety and tolerability of AUP-16 and the recommended dose for an upcoming phase 2 study. In addition, preliminary efficacy data of AUP-16 in patients with non-healing wounds will be available.

“The medical need in chronic nonhealing wounds is already massive and is growing globally due to the increasing incidence of diabetes, obesity, vascular disease and ageing. Affected patients deserve new effective therapies to stop this devastating condition that, if untreated, can lead to infection, gangrene, amputation and death” said Christoph Schindler (Medizinische Hochschule Hannover (MHH), Hannover, Germany).

Schindler, global coordinating investigator for this trial, added: “We are excited to be part of this Phase 1-2A study evaluating AUP-16, an ATMP gene therapy product that has demonstrated promising potential in preclinical studies.”

“We are extremely excited to dose the first patient in this trial with AUP-16.

This is not only a major achievement for Aurealis Therapeutics, but also for synthetic biology based multitherapy drug products such as AUP-16.” said Thomas Wirth, CSO and chairman of the board of Aurealis Therapeutics.

“AUP-16, our three-in-one combination biologics product, hitting the key wound healing targets— inflammation, proliferation and remodelling—is very different from the past single target therapies and has potential for superior clinical efficacy,” continued Juha Yrjänheikki, CEO of Aurealis Therapeutics and Roger Meier, board director and a long-time advisor of the company.

MolecuLight upgrades i:X

MolecuLight has announced the release of a “significant upgrade” to its i:X digital wound measurement feature that enables clinicians to more accurately and quickly capture digital wound area measurement. According to a statement, clinicians can now reliably detect more complex wound borders using the i:X’s Auto Mode feature and input a depth measurement.

“We and others have shown that standard of care length by width wound area measurements overestimate wound area measurements by more than 30%, which is unacceptable for tracking wound progress over time,” says Danielle Dunham, product manager

MolecuLight

for the MolecuLight i:X platform.

“With the upgrade to MolecuLight’s wound measurement feature, the device combines precise wound measurement with advanced fluorescence imaging for more accurate detection of wounds containing bacteria. This empowers clinicians with more information at the point of care for a more comprehensive wound assessment.”

Clinicians rely on accurate wound measurements to determine whether wounds are progressing and to evaluate the effectiveness of the treatment plan. The current standard of care, involving manually measuring the length and width of wounds with a ruler, leads to highly subjective, inaccurate measurements. The upgrade allows clinicians to quickly and precisely detect wound borders using MolecuLight i:X’s Auto Mode and measure wounds with greater than 95% accuracy.

Using the MolecuLight i:X, clinicians simply capture an image of the wound with MolecuLight WoundStickers next to the wound. The Auto Mode feature is based on sophisticated algorithms to precisely detect and trace the wound border and then calculate wound surface area, length and width. A new optional depth input is also included so clinicians can document their wound measurements faster and spend more time focusing on treatment of the patient and their wound.

“Smart” bandage for wound care designed by biomedical engineers at University of Connecticut

13

For the first time, faculty in the biomedical engineering department, University of Connecticut, Mansfield, USA, have designed a wirelesslycontrolled (or “smart”) bandage and a corresponding smartphone-sized platform that can precisely deliver different medications to the wound with independent dosing.

Chronic and non-healing wounds—one of the most devastating complications of diabetes and the leading cause of limb amputation— affects millions of Americans each year.

Due to the complex nature of these wounds, proper clinical treatment has been limited.

This bandage, developed by Ali Tamayol, associate professor, and researchers from the University of Nebraska-Lincoln (Lincoln, USA) and Harvard Medical School (Boston, USA), is equipped with miniature needles that can be controlled wirelessly—allowing the drugs to be programmed by care providers without even visiting the patient.

“This is an important step in engineering advanced bandages that can facilitate the healing of hard to treat wounds. The bandage does not need to be changed continuously,” says Tamayol.

Given the range of processes necessary of wound healing, different medications are needed at different stages of tissue regeneration. The bandage—a wearable device—can deliver medicine with minimal invasiveness.

With the platform, the provider can wirelessly control the release of multiple drugs delivered through the miniature needles. These needles are able to penetrate into deeper layers of the wound bed with minimal pain and inflammation. This method proved to be more effective for wound closure and hair growth, as compared to the topical administration of drugs, and is also minimally invasive.

The research, recently published in the Advanced Functional Materials journal, was first conducted on cells and later on diabetic mice with full-thickness skin injury. With this technology, the mice showed signs of complete healing and lack of scar formation—showing the bandages’ ability to significantly improve the rate and quality of wound healing in diabetic animals.

These findings can potentially replace existing wound care systems and significantly reduce the morbidity of chronic wounds—which will change the way diabetic wounds are treated according to the University of Connecticut.

Connecticut wound bandage

14

June 2020 | Issue 03

Market watch

Clinical News Phase 3 trial for D-PLEX100 technology to assess efficacy in preventing sternal wound infection

Pharmaceutical company PolyPid has announced that the first patient has been enrolled and randomised in a phase 3 clinical trial called SHIELD (Surgical site Hospital-acquired Infection prEvention with Local D-plex). SHIELD will evaluate PolyPid’s D–PLEX100, plus standard of care, versus standard of care only for the prevention of sternal wound infection post-cardiac surgery.

According to a statement, PolyPid’s D-PLEX technology enables prolongedrelease therapeutics for the treatment of wound infections. Juan A Crestanello, a cardiovascular and thoracic surgeon at Mayo Clinic, Rochester, USA, is the principal investigator of the SHIELD study.

SHIELD is a prospective, multinational, multicentre, blinded, randomised study designed to assess the efficacy and safety of D-PLEX100 in the prevention of sternal wound infection post-cardiac surgery. The primary endpoint of the trial is the infection rate, as measured by the proportion of subjects with a sternal wound infection event within 90 days post-sternotomy.

The trial will enrol a minimum of 1,284 subjects, with a maximum of about 1,600 subjects, as defined by the adaptive study design, in approximately 45 centres across the USA, Europe and Israel.

PolyPid previously completed a single-blinded and double-arm randomised phase 1b/2 trial, evaluating the safety and efficacy of D– PLEX100, plus standard of care, versus standard of care only, in the prevention of sternal wound infection post-cardiac surgery.

In this trial, none of the 58 patients treated with D‐PLEX100 plus standard of care had a primary sternal wound infection within 90 days post-surgery, as compared to one of the 23 patients in the standard of care arm, representing a 4.3% infection rate. Additionally, in the D–PLEX100 plus standard of care arm, 3.4% of patients were treated with IV antibiotics directly due to a sternum wound discharge adverse event, as compared to 21.7% in the standard of care only group.

D–PLEX100 was observed to be generally well-tolerated, with no drugrelated severe adverse effects and no drug-related wound healing issues at the incision site.

RECELL System

First patient enrolled in study evaluating RECELL System for soft tissue reconstruction

AVITA Medical has announced the initiation of a study into soft tissue reconstruction with the enrolment of the first patient at the Arizona Burn Center (Valleywise Medical Health Center, Phoenix, USA). According to a statement, this study will evaluate the safety and effectiveness of the RECELL System when used as an adjunct to meshed autografts in patients undergoing reconstruction of skin defects not associated with a burn injury.

Skin grafting is the standard of care for full-thickness, soft tissue reconstruction, including post-trauma and post-surgical skin reconstruction.

While skin grafting is commonly associated with burn treatment, in 2017 approximately 80% of acute wounds that required skin grafting were non-burn related injuries accounting for more than 200,000 procedures in the USA The prospective multicentre trial of

at least 65 patients will compare the clinical performance of conventional skin grafting to the use of the RECELL System in combination with more widely meshed autografts on acute full-thickness non-burn skin defects. The study’s two primary effectiveness endpoints are: Superior donor skin sparing, evaluated by comparing the actual expansion ratios of donor skin used to treat the wounds Non-inferior incidence of healing by eight weeks post treatment Healing will be evaluated by a qualified clinician blinded to the treatment allocation. Additional long-term safety and effectiveness data collected over the course of the 52-week study will include blinded evaluation of scar outcomes and patient treatment preference.

The pivotal studies leading to the RECELL System’s FDA premarket approval for the treatment of acute thermal burns demonstrated that the RECELL System treated burns using 97.5% less donor skin when used alone in second-degree burns, and 32% less donor skin when used with autograft for third-degree burns.

Despite the statistically significant reduction in donor skin required to treat burn patients with the RECELL System, burn wounds treated with the RECELL System achieved healing comparable to the burn wounds treated with standard of care.

Calendar of events 26 May - 25 June CX 2020 LIVE Virtual

Please be advised that the events listed opposite, because of COVID-19, are subject to change. Please check the relevant website for further details as the event may be cancelled, postponed, or become a virtual event.

cxsymposium.com/cx-2020-live/

22–26 July SAWC Spring: Symposium on Advanced Wound Care Charlotte, USA www.sawcspring.com

23–26 July APMA: American Podiatric Medical Association Boston, USA www.apma.org

13–17 September WUWHS: World Union of Wound Healing Societies Abu Dhabi, UAE

1–3 October iWounds Symposium Chicago, USAE www.iwoundssymposium.com

18–20 November EWMA: European Wound Management Association London, UK www.ewma.org

www.wuwhs.com

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| Issue 01

Edmonds:

Diabetic foot A new era

care: Page 6

William Ennis:

Profile

Page 12

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