Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft

Area of Science:

• Wound healing research
• Regenerative medicine
• Biomaterials in medicine

Background:

• Randomized controlled trials (RCTs) often exclude over 50% of wound populations due to strict criteria, limiting real-world applicability.
• Generalizing RCT outcomes to diverse patient populations in wound care remains a challenge.
• Decellularized, dehydrated human amniotic membrane (DDHAM) is a potential therapeutic option for chronic wounds.

Purpose of the Study:

• To evaluate the outcomes and clinical experience of using DDHAM in uninfected, full- or partial-thickness wounds.
• To observe the efficacy of DDHAM in a real-world setting with heterogeneous wound types and patient conditions.
• To assess the safety and benefit of DDHAM in supporting wound closure.

Main Methods:

• A registry study involving 15 sites and practicing wound care clinicians.
• Inclusion of 179 chronic wounds (venous, diabetic, pressure, etc.) in 165 patients, with some ulcers having failed prior advanced biologic therapies.
• Standard care was provided, with exclusions for actively infected wounds or hypersensitivity to DDHAM.

Main Results:

• Nearly 50% of chronic wounds achieved complete closure within a median of 6.3 weeks (average 8-week management).
• Factors influencing closure included infections, noncompliance, re-injury, and comorbidities.
• No product-related adverse experiences were reported.

Conclusions:

• DDHAM demonstrated safety and clinical benefit in supporting wound closure for various chronic wound types.
• The registry study confirmed DDHAM's utility in real-world clinical environments despite challenging, uncontrolled factors.
• DDHAM offers a viable option for wound management across diverse patient conditions.