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Use of amniotic membrane in hard-to-heal wounds: a multicentre retrospective study

02 September 2024
Volume 8 · Issue 2

Abstract

Objective:

Hard-to-heal (chronic) wounds negatively impact patients and are a source of significant strain on the healthcare system and economy. These wounds are often resistant to standard of care (SoC) wound healing approaches due to a diversity of underlying pathologies. Cellular, acellular, and matrix-like products, such as amniotic membranes (AM), are a potential solution to these challenges. A growing body of evidence suggests that AM may be useful for treatment-resistant wounds; however, limited information is available regarding the efficacy of dehydrated amniotic membrane (DHAM) on multi-aetiology, hard-to-heal wounds. Therefore, we analysed the efficacy of DHAM treatment in reducing the size of hard to-heal diabetic and venous leg ulcers (VLUs) that had failed to improve after SoC-based treatments.

Method:

In this multicentre retrospective study, we analysed wound size during clinic visits for patients being treated for either diabetic or VLUs. During each visit, the treatment consisted of debridement followed by application of DHAM. Each wound was measured after debridement and prior to DHAM application, and wound volumes over time or number of DHAM applications were compared.

Results:

A total of 18 wounds in 11 patients were analysed as part of this study. Wounds showed a significant reduction in volume after a single DHAM application, and a 50% reduction in wound size was observed after approximately two DHAM applications. These findings are consistent with reports investigating DHAM treatment of diabetic ulcers that were not necessarily resistant to treatment.

Conclusion:

To our knowledge, this study is the first to directly compare the efficacy of standalone DHAM application to hard-to-heal diabetic and venous leg ulcers, and our findings indicate that DHAM is an effective intervention for resolving these types of wounds. This suggests that implementing this approach could lead to fewer clinic visits, cost savings and improved patient quality of life.

Approximately 8.2 million Medicare beneficiary patients in the US have a hard-to-heal (chronic) wound, and this number is likely to increase as the population continues to age.1 These wounds significantly impact patients' quality of life (QoL) and functional status, while also increasing their overall mortality. Moreover, hard-to-heal wounds are expensive. Estimated Medicare costs range from $28.1–96.8 billion USD per year in wound care alone, with an estimated $24.3 billion USD spent on outpatient therapy, often aimed at scar reduction.2

The diversity of patients' underlying pathophysiology is a major influence on the complexity of hard-to-heal wounds and the appropriate course of treatment. Hard-to-heal wounds are broadly defined as wounds arising from external trauma resulting in chronic inflammation which disrupts tissue architecture and leads to circulatory deficits.3 This causes continuous ischaemic damage and prevents wound healing by disrupting effective tissue granulation and re-epithelialisation.4 While there are multiple hard-to-heal wound aetiologies, in this present study, we focus on the two most common: diabetic ulcers and chronic venous insufficiency (CVI)-induced ulcers.

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