Amnion Membrane Powder Mohs Study

A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Heal
• Intervention / Treatment: Drug: Amnion Membrane Powder; Drug: Standard of Care

Detailed 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 topical application with the purpose of enhanced wound healing.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Mary-Clare Day; Phone Number: 336-713-1343; Email: maryclare.day@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
      • Contact: Mary-Clare Day; Phone Number: 336-713-1343; Email: maryclare.day@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 and/or guardian is/are able to read and understand instructions and give informed, voluntary, written consent.
• The subject is able and willing to follow the protocol requirements.

Exclusion Criteria:

• The subject's wound site is smaller than 4cm2.
• The subject's wound site does not extend to the subgalea.
• The subject has invasive melanoma or high-risk squamous cell carcinoma (defined by poor differentiation, presence of perineural invasion) in which the standard of care is to be referred for adjuvant radiation oncology
• The subject has a microbiologically proven pre-existing local or systemic bacterial infection.
• The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting.
• Unstable cardiac disorders within the past 6 months including angina, abnormal ECG, history of cardiac arrest, surgery and/or other interventional procedure that would preclude the indicated procedure.
• Hepatic disease or altered liver function as defined by ALT or AST value > 3 times the upper limit of normal and/or T. Bilirubin >1.5 mg/dL at screening.
• Renal disease or altered renal function as defined by serum creatinine > 2 mg/dL at screening, or ESRD.
• Hemoglobin <10.0 or >19.0 g/dL
• Untreated coagulopathy or platelet disorder, or INR > 1.6, PTT > 38 sec; PLT < 50,000 at screening.
• The subject is known to have a pre-existing, chronic condition that, in the opinion of the Investigator, may interfere with complete re-epithelialization including but not limited to untreated malignancy, uncontrolled diabetes (HbA1c >10), autoimmune disease or other immunocompromised diseases, hematological diseases, peripheral artery diseases, and /or malnourishment with an albumin < 2.5.
• The subject currently uses illicit substances or has drug or alcohol dependency.
• The subject is unable to follow the protocol.
• The subject is taking medication known to have an effect on wound healing or skin pigmentation within 30 days prior to surgery (e.g. corticosteroids, retinoids etc.)
• The subject has a known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution.
• The subject is pregnant or lactating or intends to become pregnant during the study.
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Amnion Membrane Powder; amnion membrane power applied during MOHS scalp surgery	Drug: Amnion Membrane Powder; amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery
Active Comparator: Standard of Care; aquaphor ointment applied during MOHS scalp surgery	Drug: Standard of Care; aquaphor ointment applied during MOHS scalp surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Infection	Number of participants that developed a wound infection	Through week 16
Number of Participants with Allergic Reaction	Number of participants with an allergic reaction to the intervention	Through week 16
Number of Treatment-Related Adverse Events	Number of treatment-related adverse events	Through week 16
Number of Unscheduled Visits for Wound Bleeding	Number of participants that had an unscheduled visit for wound bleeding	Through week 16
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Baseline
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 1
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 2
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 3
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 4
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 5
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 6
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 7
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 8
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 12
Pain Score	Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time Until Wound Closure	Number of days until wound was completely closed	Through week 16
Time Until of Wound Closure	Number of days until wound was fully sealed	Through week 16
Percentage of Re-epithelialization	Percentage of the wound with re-epithelialization	Week 1, week 4, week 8, week 12, week 16

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Christine Ahn, MD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: MOHS surgery; amnion membrane powder; scalp wound healing
• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: IRB00151720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No