September 2018

Advancements in Wound Healing Management

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A look at the latest research in the management of acute skin trauma for lower extremity wounds.

By Keith Loria

Skin trauma to the lower extremities—blisters, lacerations, incisions, and punctures—are common for those participating in athletic and recreational activities and are seen every day in clinical care settings. A foot ulcer, an open sore on the foot, is a more serious form of skin trauma or wound that occurs, often brought on in an environment compromised by diabetes or any illness that decreases circulation to the feet. Wounds in the Medicare population alone are estimated to cost the United States $31.7 billion annually according to a 2017 report from the Alliance for Wound Care Stakeholders. Treating them successfully and quickly is obviously a high priority.

Data show that controlled environments are more beneficial for wound healing compared to environments that might be open to potential outside contamination.1 Proper healing needs a wound bed that is

  • well vascularized,
  • free of devitalized tissue,
  • clear of infection, and
  • moist.

Only when wounds demonstrate progressive healing (granulation tissue and epithelialization), should they undergo closure or coverage.1 The goal then is to create an environment that promotes healing of the wound and lessens the risk of complications.

Dressings are one way to create that environment. When a suitable dressing is applied to a wound and changed appropriately, the dressing can have a significant impact on how quickly the wound heals, how strong the wound closure will be, the capacity of the repaired skin, and the aesthetic appearance of the scar.

Here’s a sampling of recent research on various kinds of dressings.

Occlusive dressings are designed to interact with the wound to create an optimal environment
for healing.

NATA recommends occlusive dressings

In early 2017, the National Athletic Trainers’ Association (NATA) published a position statement, Management of Acute Skin Trauma,2 in which it recommended that occlusive dressings “should” be used as primary dressings in many of these cases, while non-occlusives “could” be used.

The paper noted that the area of acute skin trauma should be covered with non-occlusive dressings (eg, sterile gauze, non-adherent pads, adhesive strips and patches) or occlusive dressings (eg, films, foams, hydrocolloids) to support the healing process, rather than be left uncovered until fully healed.

“The goal in treating acute skin trauma is to achieve rapid healing while providing optimal function and cosmetic results and minimizing adverse events,” said Joel W. Beam, EdD, LAT, ATC, professor and chair, department of Clinical and Applied Movement Sciences at Brooks College of Health, University of North Florida, Jacksonville, Fla. “Occlusive dressings are designed to interact with the wound to create an optimal environment for healing (ie, a moist, clean, warm environment) and lessen the risk of infection and adverse reactions.”

To gather research, Beam, a former athletic trainer working with football players, needed to come up with a standardized method to make wounds on people. Since the most frequent wound that athletes get are blisters, he found research that had used 60-grit autoclaved SandBlaster sandpaper to make abrasions, and through pilot work and making a lot of wounds on his own leg, the researchers came up with a method to make that happen.

“The next thing we needed to develop was a method to analyze wound healing. We took pictures of the wound and analyzed them using Adobe Photoshop,” he said. “This allowed us to look at the contraction of the wound over time, and we also looked at two other measures called chromatic red and luminance (measure of red, green, and blue). We looked at hydrocolloids, film, hydrogel, and no dressing in one study and four different occlusive dressings in the other.” 3

For the study, 16 people (10 women and 6 men) were inflicted with four standardized, partial-thickness abrasions. Film, hydrogel, and hydrocolloid occlusive dressings and no dressing (control) were applied and the participants returned on post-wound days 1, 3, 5, 7, 10, and 14 for digital imaging.

When compared with the control (no dressing) 4, the film, hydrogel, and hydrocolloid occlusive dressings were associated with a faster healing rate of partial-thickness abrasions across time measured by wound contraction, color, and luminance, indicating that occlusive dressings were more effective in healing than no dressing.

“Most acute skin trauma heals without consequence, although it is important to manage these wounds through appropriate cleansing, debridement, and dressing techniques to lessen the number of poor outcomes and allow functional return to activity as quickly as possible,” Beam said.

Wound care costs in Medicare beneficiaries*

In the first comprehensive study of Medicare spending on wound care, the cost of chronic wound care for Medicare beneficiaries was analyzed and calculated by wound type and by care setting:

  • Chronic wounds impact nearly 15% of Medicare beneficiaries (8.2 million).
  • A conservative estimate of the annual cost is $28 billion when the wound is the primary diagnosis on the claim. When the analysis included wounds as a secondary diagnosis, the cost for wounds is conservatively estimated at $31.7 billion.
    • Surgical wounds and diabetic foot ulcers drove the highest total wound care costs (including cost of infections).
    • On an individual wound basis, the most expensive mean Medicare spending per beneficiary was for arterial ulcers followed by pressure ulcers.
    • In regard to site of service, hospital outpatient settings drove the greatest proportion of costs – demonstrating a major shift in costs from hospital inpatient to outpatient settings.
    • Surgical infections were the largest prevalence category, followed by diabetic wound infections.

*Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and Medicare policy implications of chronic nonhealing wounds. Value in Health. 2018;21(1):27-32.

Occlusive vs non-occlusive dressings

The NATA’s position statement attracted the interest of Dan Baer, PhD, LAT, ATC, department of sports medicine at West Chester University, West Chester, Pa., who, during preseason of football camp, gave the article to athletic training student Sean McCann to read through and summarize for the rest of the students working with football players.

“We had our standard way that we deal with open wounds and the way we dress them, and we wanted to see if occlusive dressing was indeed better,” Baer said. “We were curious and thought it was an important thing to look at.”

McCann led a comparison study, A Case Study Evaluating the Efficacy and Cost-Effectiveness of Two Acute Wound Management Strategies,5 that looked at utilizing different dressings to cover wounds; he opted to compare one lower extremity wound and one upper extremity wound, to see if there were any outstanding differences in the application of the two different types of dressings, as well as the impact it had on the budget.

“Our current practice was to use non-occlusives, so we were curious to see the effectiveness of the occlusives,” McCann said.

NCAA Division 2 Football players were studied, one with a superficial knee abrasion, one with a superficial elbow abrasion. Both wounds were cleansed using the guidelines recommended by the NATA position statement. One wound was covered with an occlusive and one was covered  by a non-occlusive.

“The NATA recommended that the non-occlusive was changed every day, or after a training bout, so we changed it before and after practice,” McCann said. “The occlusive is supposed to be left on for up to 7 days at a time. But it would come off due to the demands of the sport, so it was changed as necessary. We followed both cases until the wound showed signs it had healed, then looked at the total cost of covering each wound.”

Over the 2-week period, neither of the 2 cases studied contracted any pathologies, and both wounds showed similar signs of proper healing. However, the occlusive strategy cost 5 times more than the non-occlusive on a day-to-day basis.

“We knew the occlusive would cost more, but were surprised that it was 5 times greater. For an athletic trainer who covers many wounds over a season, this would lead to thousands of dollars lost due to the cover of wounds with occlusives,” McCann said. “The only noticeable difference was the amount of scarring present. The quality of the skin from the wound covered by the occlusive was much smoother and less granulated.”

Baer believes the study should be repeated on a larger scale and with other sports, allowing for a larger variance of wound types and locations, as well as different levels of contact, as there may be wound types, locations, or sports where the cost of using an occlusive may be reduced.

dHACM and diabetic foot ulcers

As in other medical fields, technology is driving innovation in wound care. William Tettelbach, MD, associate chief medical officer for MiMedx, Marietta, Ga., noted that technological advances in and utilization of human amnion/chorion derived tissues have been increasing rapidly over the past decade.

Derived from the human placenta, MiMedx’s dehydrated Human Amnion/Chorion Membrane (dHACM) tissues have been shown in clinical trials to promote the migration of stem cells in vitro and to recruit stem cells to a wound site in vivo, promoting epithelialization, reducing pain and inflammation, and enhancing soft-tissue healing—all while having antibacterial properties.6

MiMedx uses a proprietary PURION® process to clean, dehydrate, and sterilize human amniotic/chorionic membrane while retaining important attributes (extracellular matrix materials, growth factors, and cytokines) of the natural amniotic membrane.Specific immunohistochemical testing and ELISA testing have been used to document this equivalence both qualitatively and quantitatively.

Tettelbach’s recently published study looked at the efficacy of dHACM allografts in diabetic foot ulcers.8 The study sought to determine the safety and effectiveness of dHACM plus standard of care (SOC) for the treatment of non-healing diabetic foot ulcers compared to SOC alone, which was defined as sharp debridement, offloading, when indicated, and an alginate dressing.

“Favorable evidence among early clinical adopters and clinical trials have been increasing over this time,” said Tettlebach.

Fourteen study sites across the United States enrolled 110 patients in the randomized controlled trial;  clinical investigators included both podiatrists and medical doctors. The primary endpoint was complete closure of the diabetic foot ulcer at 12 weeks. The treatment cohort received dHACM plus the SOC, while the SOC cohort received SOC only.

“The chief takeaway was that dHACM showed an 81% wound closure rate in the per protocol (PP) population vs. 55% wound closure rate in the SOC control protocol population (dHACM + SOC 81% vs. SOC 55%, p=0.0093),” Tettelbach said. “In intent-to-treat (ITT) basis, 70% of patients who received weekly dHACM had complete healing by 12 weeks versus 50% of patients only receiving weekly SOC (dHACM 70% vs. SOC 50%, p=0.0338).”

Furthermore, in the ITT cohort, adjusting for co-variates associated with healing, Cox regression analysis showed patients treated with dHACM were more than twice as likely to heal completely within 12 weeks as those who did not receive the product.

The study supports past clinical trials whereby dHACM demonstrated complete wound closure to treat lower extremity ulcers in a heterogeneous patient population.9 It also showed that dHACM continues to be a viable treatment option for wound-care providers to consider when stalled diabetic foot ulcers require an improvement in wound closure.

While adequate debridement of chronic wounds is critical, Tettelbach said that based on the results, the combination of adequate debridement combined with the application of dHACM may substantially increase the likelihood of achieving complete wound closure vs. SOC.

“A secondary finding was the corroboration that adequate sharp debridement is a crucial step in wound-bed preparation needed to address the inflammation/infection stage of wound healing,” Tettelbach said. “Subjects identified in the study as having inadequate debridement were 64% less likely to heal within 12 weeks when controlling for other significant factors in the model.”

Keith Loria is a freelance writer who writes regularly for LER.

REFERENCES
  1. Armstrong DG, Meyr AJ. Basic principles of wound management. UpToDate. 2013. Available at https://www.uptodate.com/contents/basic-principles-of-wound-management.
  2. Beam JW, Buckley B, Holcomb W, Ciocca M. Management of acute skin trauma. J Athl Train. 2016;5(12):1053-1070.
  3. Beam JW. Effects of occlusive dressings on healing of partial-thickness abrasions. Athl Train & Sports Health Care. 2012;4(2):58-66.
  4. Beam JW. Occlusive dressings and the healing of standardized abrasions. J Athl Train. 2008;43(6):600-607.
  5. McCann ST, Baer D, Smith JJ. A case study evaluating the efficacy and cost-effectiveness of two acute wound management strategies. Poster presented at 2018 National Athletic Trainers Association Annual Meeting, New Orleans, LA. June 2018.
  6. Lei J, Priddy JB, Lim JJ, Koob TJ. Dehydrated human amnion/chorion membrane (dHACM) allografts as a therapy for orthopedic tissue repair. Tech Orthop. 2017;32(3):149-157.
  7. Koob TJ, Rennert R, Zabek N, Massee M, Lim JJ, et al. Biological properties of dehydrated human amnion/chorion composite graft: implications for chronic wound healing. Int Wound J. 2013;10: 493-500.
  8. Tettelbach W, Cazzell S, Reyzelman AM, Sigal F, Caporusso JM, Agnew PS. A confirmatory study on the efficacy of dehydrated human amnion/chorion membrane dHACM allograft in the management of diabetic foot ulcers. Int Wound J. 2018 Aug 22. doi: 10.1111/iwj.12976. [Epub ahead of print]
  9. Spichler A, Hurwitz BL, Armstrong DG, Lipsky BA. Microbiology of diabetic foot infections: from Louis Pasteur to ‘crime scene investigation’. BMC Med. 2015;13:2.
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