“Chronic wounds affect 10.5 million of U.S. Medicare beneficiaries. Chronic wounds impact the quality of life of nearly 2.5% of the total population of the United States.”[1]
A chronic wound is defined as a wound that has not progressed through the normal process of healing and are open for more than a month.[2] The major types of chronic wounds include vascular (arterial and venous), diabetic (neuropathic), combination such as venous stasis ulcer and diabetic ulcer, and pressure ulcers. The most common type of chronic wounds are venous stasis ulcers affecting 3-5% of those 65 years and older and will reoccur after healing in approximately 50-76% of cases.[3] In the last several years, bioengineered skin and soft tissue substitutes used for treatment of ulcers have flooded the market, with more than 175 products currently available.
The US Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Skin substitutes are typically regulated by the FDA under one of the following pathways: Human Cells, Tissues, And Cellular and Tissue-Based Products (HCT/Ps), Premarket Approval (PMA), 510(k) Premarket Notification, or Humanitarian Device Exemption (HDE). Products that reach the market through the HCT/P process do not require any testing to prove clinical safety or efficacy. However, the manufacturer must meet specific FDA regulations for the collection, processing, and selling of HCT/Ps.[4] This market is projected to be worth US $ 2.4 billion in 2024 and anticipated to reach US $ 3.5 billion by 2034.[5]
Recently, we have seen individual claims exceeding $1M for bioengineered skin and soft tissue substitutes. With the number of products available that do not require any testing to prove clinical efficacy, what is your approach to these products? Is there well documented research to support the use of the product? You may want to consider the following:
What is the frequency and duration of use of these products?
Have underlying causes/barriers to healing been addressed? These might include: adequate circulation to the affected extremity, optimal glucose control, debridement of necrotic tissue, minimum of 4 weeks of standard wound care without any measurable signs of improvement, and whether infection, malignancy and structural abnormalities have been ruled out.[6]
Chronic wounds may take years to heal and are impactful to a patient’s quality of life, but they can also be a financial burden. In fact, it is estimated that chronic wounds cost the United States healthcare system $28 billion each year. [7] As new products come to market, it is essential that efficacy has been established to justify the treatment that the patient is undergoing as well as the cost.
Article by Kathy Clark, RN, BSN, CMCN, Vice President, Director of Managed Care. For more information about how this may affect your plan, please contact your Summit ReSources care specialist. The following sources were used as reference material for this article:
[1] Sen CK. Human Wound and Its Burden: Updated 2020 Compendium of Estimates. Adv Wound Care (New Rochelle). 2021 May;10(5):281-292. doi: 10.1089/wound.2021.0026. PMID: 33733885; PMCID: PMC8024242. Accessed 4/12/2024. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8024242/#B7
[2] Chandan K. Sen. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Advances in Wound Care 2023 12:12, 657-670. Accessed 4/12/2024. https://www.liebertpub.com/action/showCitFormats?doi=10.1089%2Fwound.2023.0150
[3] Chandan K. Sen. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Advances in Wound Care 2023 12:12, 657-670. Accessed 4/12/2024. https://www.liebertpub.com/action/showCitFormats?doi=10.1089%2Fwound.2023.0150
[4] Tissue Engineered Skin Substitute Market Outlook from 2024 to 2034. Future Market Insights, Inc. Accessed 4/11/2024. https://www.futuremarketinsights.com/reports/tissue-engineered-skin-substitute-market
[5] Bowers S and Franco E (2020) Chronic Wounds: Evaluation and Management Am Fam Physician. 2020;101(3):159-166. Accessed 4/12/2024.https://www.aafp.org/pubs/afp/issues/2020/0201/p159.html#:~:text=Chronic%20wounds%20should%20never%20be,have%20less%20risk%20of%20infection.&text=If%20a%20wound%20appears%20dry,appropriate%20dressing%20(Table%203).
[6] Vecin NM and Kirsner RS (2023) Skin substitutes as treatment for chronic wounds: current and future directions. Front. Med. 10:1154567. doi: 10.3389/fmed.2023.1154567.
[7] Chandan K. Sen. Human Wound and Its Burden: Updated 2022 Compendium of Estimates. Advances in Wound Care 2023 12:12, 657-670. Accessed 4/11/2024. https://www.liebertpub.com/action/showCitFormats?doi=10.1089%2Fwound.2023.0150