A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites
Wake Forest University Health Sciences
Summary
The purpose of this research study is to test the safety of the amnion membrane powder to see if it improves wound healing in patients undergoing Mohs surgery on the scalp.
Description
The primary objective of this prospective, non-randomized, controlled study is to assess the safety of the human amnion membrane powder for enhanced wound healing properties in patients undergoing Mohs surgery resulting in full thickness wounds. The secondary objective is to evaluate the efficacy of the product relative to the standard of care treatment in a control cohort of subjects. The treatment site will be the wound created by the Mohs surgery in the treatment group. The proposed sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topica…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * The subject requires Mohs surgery on the scalp, with the resulting wound extending to the subgalea (all subcutaneous fat removed) and a surface area of at least 4cm2. * The subject is willing to complete all follow-up evaluations required by the study protocol. * The subject is to abstain from any other covering or treatment of the wound(s) for the duration of the study unless otherwise directed by the study surgeon or their surrogate * The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. * The subject an…
Interventions
- DrugAmnion Membrane Powder
amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery
- DrugStandard of Care
aquaphor ointment applied during MOHS scalp surgery
Location
- Atrium Health Wake Forest BaptistWinston-Salem, North Carolina