March - April 2023
MasterSeries 60 Minutes Interactive
Topical Oxygen Therapy: All Your Questions Answered
Introduction
This MasterSeries is on Topical Oxygen Therapy. We have a global panel of experts who have been using this form of cyclical topical oxygen for many years in their clinical practice. We will be delving into the clinical indications for the usage, the types of patients that generally benefit, how to administer the therapy, as well as substantial evidence for the usage. We get a personal view with tips and tricks as well as other pearls of clinical wisdom. You will have the opportunity to watch the whole interactive, immersive event at this link:
woundmasterclass.com/Video
Our global experts joining us for this MasterSeries are Dr Matthew G. Garoufalis, Past President of the American Podiatric Medical Association; Frank Aviles of the Natchitoches Regional Medical Center; Dr Anil Hingorani, vascular surgeon; Kara Couch, director of wound care services at George Washington University Hospital, and Dr Paul Haser, vascular surgeon.
The Role of Oxygen in Wound Healing
Oxygen therapy has been very helpful in treating a variety of wounds in recent times. It has been used in Sickle Cell Disease (SCD), radiation burns, and pyoderma gangrenosum, that has been very difficult to treat. With more and more success stories, there has been a huge change at the molecular level, changing the way that cells function and the way they communicate to each other and therefore allowing healing to finally occur in these hard-to-heal wounds.
The scope for the wounds that can be amenable to oxygen therapy is quite wide, and yet there still remains a large percentage of the population of clinicians, nurses and hyperbaric technicians that are reluctant to incorporate oxygen therapy into their clinical practice, as part of an advanced modality to be used alongside standard of care.
How is Oxygen Delivered to the Wound?
For topical oxygen therapy, presently there is continuous diffusion, which has been around for a while with a variety of devices; and then there is cyclical pressurised topical oxygen, which is a newer
technology having been around for about ten years now; this method actually drives oxygen into the wound under pressure. This is how I first became involved with topical oxygen; I had used many devices in the past, and with an understanding of hyperbarics, but not always having access to that, which in my hands at least did not always get good or consistent results. So when cyclical pressure topical oxygen became available, I was interested in it from a scientific point of view because I understood the theories behind it from my experience in lymphedema and venous stasis treatment. Even though there was no science at that time in 2015, for this reason I started to use it in my practice.
Now, however, continuous diffusion and cyclical pressure devices do have some very good science and studies. Cyclical pressure now has level 1A Randomized Controlled Trials (RCT’s) and excellent studies which have all been reviewed and accepted into medical literature. We are in a much better position with this modality than we were many years ago.
Evidence Base
At time of writing, there has been a plethora of articles that have been peer reviewed and published. I will review two studies on cyclical pressure topical oxygen that gives us some remarkable data.
The first is an RCT that was able to demonstrate that using this modality we were able to heal wounds sixtimes faster in twelve weeks, with a recurrence rate six-times lower at one year, compared with the study arm that did not get topical oxygen.1
The second is a real world evidence study that was done in a Veteran’s Affairs (VA) population, which as most of us will understand is a population with many co-morbidities. This study was conducted in two different sites with two hundred patients. All the patients in the study were undergoing regular treatments for their wounds using skin substitutes, grafts, different dressings, etc. They were all receiving top line modalities to heal their wounds,
the only difference being that one arm received cyclical pressurised topical oxygen therapy, the other arm did not. This study was able to demonstrate an 88% reduction in hospitalizations after one year, and a 71% reduction in amputations after one year, in the group that got oxygen therapy.2
This evidence tells us that this is a modality that can make a difference in patient’s lives, and also make a difference in costs.
We now have data that is definitive, peer-reviewed and has undergone meta-analysis by several different groups that were all extremely positive.
Limb Assessment and Patient Selection
The patient need to be assessed for adequate blood flow, whether the wound has been debrided adequately, and that they are relatively free of infection. A four-week model of good wound care and good standard of care medicine like collagen or foam is a good start. The patient’s wound needs to be measured in size and needs to progress by 50% by the end of the four-week model. If by the end of the four weeks there wasn’t a decrease in size by 50%, different modalities must be used, such as skin substitutes. Topical oxygen, being an adjunctive therapy, can be used at the four-week level, however those who have used it and seen its efficacy are more encouraged to use it. Patients that have undergone topical oxygen initially had a huge difference in their recovery times and in the way the wound closed because the hypoxic level of that chronic wound was unaffected.
Wound assessment is key, since you have to pick the right wound. Many of these patients have to go to revascularization before treatment is started to make sure that there is enough blood supply to heal the wound.
Coverage
Right now, the coverage in the U.S. is only in the VA setting. In New York it is covered by Medicaid,
“We now have data that is definitive, peer-reviewed and has gone under meta-analysis by several different groups that were all extremely positive.”
however that will soon be changing as Medicaid in other states will begin paying for it, hopefully, in the coming new year. We also hope that the Centers for Medicare and Medicaid Services (CMS) will allow it to be covered by CMS, at which point we think that not only will it have CMS and Medicaid coverage, but the private insurers will then fall in line, too. Right now, the most restrictive part of the coverage is in New York Medicaid where the wound needs to be present for at least thirty days, and then it is reassessed every 30 days, which is appropriate, but other than that there are no other restraints on when and how this technology is used.
Technical Challenges
This modality can certainly be used with compression hosiery because oxygen can penetrate. It is very challenging to put on and take off compression hosiery, so if the patient doesn’t have to do that, things are much easier. This technology can also be used with compression wraps, such as a multilayer compressive system; it can penetrate all these materials. It has been used with total contact casts many times, and the technology has been developed with these things in mind, such as to accommodate a total contact cast.
Conclusion
I was the biggest sceptic in the world about topical oxygen. After many years of practice and now having used it on hundreds of patients, I’ve now decided to become the CMO of that company, in order to educate others on what this can do for their patients and practice.
Incorporation of Oxygen Into Wound Healing Therapy
In the beginning, topical oxygen got a bad reputation because, initially, there were very poor studies. The evidence now, however, for its use in many conditions, is significant. For practitioners, the way they practice will definitely change as soon as the results are noticed.
We know the importance of oxygen in that it is vital to sustain life, but after having an injury the vasculature in the body will limit the oxygen to the area. Having a hypoxic wound is needed and that’s acute hypoxia, because that’s what starts some of the processes, but when you have inflammation that is going to increase the oxygen demand. So, if you have prolonged hypoxia, that wound is not going to move to the proliferative phase. The oxygen has to get to the actual site. With inflammation, it is well known that oxygen helps with taking care of bacteria, and angiogenesis, but if we have this hypoxic wound, we are not going to progress.
Also, nutrition and cell health is a very important factor that needs to be considered. If the metabolic cell does not have adequate nutrients and oxygen getting to it, it will be very inactive.
“Oxygen helps with taking care of bacteria, and angiogenesis, but if we have this hypoxic wound, we are not going to progress.Global expert Mr Frank Aviles Natchitoches Regional Medical Center
Application
When we were first introduced to topical oxygen, we were very sceptical. We therefore used this modality on patients with whose wounds we had tried everything, given optimal care, and nothing had worked. We were amazed at how quickly some of these patients turned around.
The application of the technology is quite broad, and this is definitely one of the advantages. When it comes to patients with significant infection, this modality helps. The oxygen is toxic to bacteria; we have evidence from studies that infection is better with these patients receiving topical oxygen therapy in terms of wound cultures.
This is an adjunctive technique to what you are already doing; you’re already assessing the arteries, veins, local wound care, infection, etc. This modality adds to what you’re already doing, and augments the healing. It doesn’t change what you’re doing. You can leave it over almost any type of dressing, even those that are all the way up to the knee.
they are in the intensive care unit, etc. Any level of amputation is terrible for the patient, of course, but for the upper extremities the prosthetic technology has not really caught up, and these patients have a much more difficult time than those with lower extremity amputations.
Another group of patients would be those who suffer from Raynaud’s syndrome, a very painful condition that can result in wounds. This modality would help them, particularly in the winter. These are patients that we sometimes bring into the hospital for IV treatment for five days, but this would be a much preferable treatment, especially in an outpatient setting at home.
There are a wide variety of suitable patients. I think that the key in using topical oxygen is the need for a committed patient, so that if they are using it in the outpatient setting, they are doing so consistently and you can ensure that the therapy is being done daily, or as prescribed. You have to choose the patient appropriately to ensure the best outcome.
An excellent advantage in using this modality is the rapid pain reduction. This has been the most striking thing I have noticed about this therapy in addition to the obvious healing benefits. The patients have really been so thrilled about this; I really cannot emphasise enough how badly pain impacts quality of life, and if we can get patients off pain medication, this is obviously a benefit.
What Patients Do You Use This Modality On?
We use this modality on lower extremity wounds, and I have also used it on upper extremity wounds to help with digital ischemia for patients who I cannot bring to the hyperbaric chamber because
What Patients Do You Use This Modality On?
One of the great secondary effects of topical oxygen therapy, aside from wound healing, is that it shows a marked reduction in pain. We have had a really
“An excellent advantage in using this modality is the rapid pain reduction. This has been the most striking thing I have noticed about this therapy in addition to the obvious healing benefits.”Global expert Ms Kara Couch Director, Wound Care Services at The George Washington University Hospital Arlington VA, United States Global expert Dr Paul Haser Vascular Surgeon New York City NY, United States Global expert Dr Anil Hingorani Vascular Surgeon New York City NY, United States
good compliance with the patients doing this; firstly, it is very easy to use, it’s really quite comfortable for most patients, partly because with this modality the patients often find that their wound hurts a lot less.
We consider topical oxygen therapy in diabetic patients, or those who otherwise have nonrevascularizable ischemic issues. Right now, we are limited in terms of insurance reimbursement in the U.S. but I do think at some point down the road we may decide to start this therapy immediately as a very useful adjunct to what we are already doing.
See all Wound Masterclass MasterSeries on demand: bigmarker.com/wound-masterclass
References
1. Reduced Hospitalizations and Amputations in Patients with Diabetic Foot Ulcers Treated with Cyclical Pressurized Topical Wound Oxygen Therapy: Real-World Outcomes; Advances in Wound Care; 2021
2. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers; The TWO2 Study; Diabetes Care 2020;43:616-624 | https://doi.org/10.2337/dc19-0476.
Evidence Based Therapy:
Demonstrated in both Randomized Controlled Trial and Real World Evidence to offer superior healing for Diabetic Foot Ulcers (DFUs).
A Unique Delivery System:
Targets multiple aspects of wound healing with OXYGEN, CYCLICAL COMPRESSION and HUMIDIFICATION
A Game Changer for Patients and Clinicians: Drives compliance with a self-administered, at-home therapy and overcomes traditional healthcare barriers. TWO2 can be used with gas permeable dressings, CCD, UNNA Boot and TCC.
6X 6X
88% 71% DELIVERING EXCEPTIONAL OUTCOMES
MORE LIKELY TO HEAL DFUs in 12 weeks
LOWER RECURRENCE rate at 12 months
REDUCTION in Hospitalizations at 12 months
REDUCTION in Amputations at 12 months
REAL WORLD EVIDENCE STUDY RANDOMIZED CONTROLLED TRIAL
A seamless addition to your care plan.
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