Amnion Membrane Powder Mohs Study

June 25, 2026 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Infection
Time Frame: Through week 16
Number of participants that developed a wound infection
Through week 16
Number of Participants with Allergic Reaction
Time Frame: Through week 16
Number of participants with an allergic reaction to the intervention
Through week 16
Number of Treatment-Related Adverse Events
Time Frame: Through week 16
Number of treatment-related adverse events
Through week 16
Number of Unscheduled Visits for Wound Bleeding
Time Frame: Through week 16
Number of participants that had an unscheduled visit for wound bleeding
Through week 16
Pain Score
Time Frame: Baseline
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Baseline
Pain Score
Time Frame: Week 1
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 1
Pain Score
Time Frame: Week 2
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 2
Pain Score
Time Frame: Week 3
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 3
Pain Score
Time Frame: Week 4
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 4
Pain Score
Time Frame: Week 5
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 5
Pain Score
Time Frame: Week 6
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 6
Pain Score
Time Frame: Week 7
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 7
Pain Score
Time Frame: Week 8
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 8
Pain Score
Time Frame: Week 12
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 12
Pain Score
Time Frame: Week 16
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time Until Wound Closure
Time Frame: Through week 16
Number of days until wound was completely closed
Through week 16
Time Until of Wound Closure
Time Frame: Through week 16
Number of days until wound was fully sealed
Through week 16
Percentage of Re-epithelialization
Time Frame: Week 1, week 4, week 8, week 12, week 16
Percentage of the wound with re-epithelialization
Week 1, week 4, week 8, week 12, week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Ahn, MD, Atrium Health Wake Forest Baptist

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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