Back to search results

Amnion Membrane Powder for Scalp Wound Healing After Mohs Surgery

This study is testing a product called Amnion Membrane Powder to see if it helps wounds heal better after Mohs surgery on the scalp. You could be eligible if you are at least 18 years old and need Mohs surgery on your scalp, resulting in a wound that is at least 4 square centimeters and extends to the subgalea (meaning all subcutaneous fat is removed). Researchers will compare Amnion Membrane Powder to standard care (Aquaphor ointment) to see if it causes fewer infections, allergic reactions, or other side effects. The study aims to enroll 20 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a non-randomized, controlled study with a planned enrollment of 20 participants.
What's involved
You would need to complete all follow-up evaluations required by the study protocol. The primary endpoints are measured through week 16.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for infection, allergic reactions, and adverse events through week 16.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07680023

Amnion Membrane Powder Mohs Study

Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~20 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Amnion Membrane PowderStandard of Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Infection
Measured over Through week 16
+14 more outcomes measured

Conditions

Wound Heal

Explore related trials

Wound healed

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Christine Ahn, MD · PRINCIPAL_INVESTIGATOR · Atrium Health Wake Forest Baptist

Who to contact

Mary-Clare Day
[email protected]
336-713-1343
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of Participants with InfectionThrough week 16

    Number of participants that developed a wound infection

  • Number of Participants with Allergic ReactionThrough week 16

    Number of participants with an allergic reaction to the intervention

  • Number of Treatment-Related Adverse EventsThrough week 16

    Number of treatment-related adverse events

  • Number of Unscheduled Visits for Wound BleedingThrough week 16

    Number of participants that had an unscheduled visit for wound bleeding

  • Pain ScoreBaseline

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 1

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 2

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 3

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 4

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 5

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 6

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 7

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 8

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 12

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.

  • Pain ScoreWeek 16

    Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.