Amnion Wound Covering for Enhanced Wound Healing

Status Completed

Clinical Trial Summary

The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

Clinical Trial Description

Extensive burns and full thickness skin wounds can be devastating to patients, even when treated with our current standard of care. There are an estimated 500,000 burns treated in the United States each year. Moreover, in the military environment, soldiers who suffer from extensive burn injuries on the battlefield may benefit from rapid treatments that result in complete closure and protection of the wounds. As such, there is a need for mobile platform technologies that allow fast treatment at the site where the injury occurred, or at the very least at the forward operating sites. This safety investigation of a human amnion membrane powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects undergoing donor skin graft harvest. The single-center study will include patients undergoing donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm gap, of donor site wounds in comparable skin locations, are available for covering with the amnion membrane product and the current institutional standard of care (SOC) covering. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing. The primary objective of the study is to evaluate the safety of a human amnion membrane product intended for enhanced wound healing. The secondary objective is efficacy as evidenced by complete wound closure relative to standard of care (SOC) treatment in a similar wound on the same subject at donor sites created for skin grafts at 14 days and 28 days postoperatively. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03754218
Study type	Interventional
Source	Wake Forest University Health Sciences
Contact
Status	Completed
Phase	Early Phase 1
Start date	December 1, 2019
Completion date	November 22, 2023

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