NCT07680023

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
12mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Wound Heal

Keywords

MOHS surgeryamnion membrane powderscalp wound healing

Outcome Measures

Primary Outcomes (15)

  • 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 Outcomes (3)

  • Time Until Wound Closure

    Through week 16

  • Time Until of Wound Closure

    Through week 16

  • Percentage of Re-epithelialization

    Week 1, week 4, week 8, week 12, week 16

Study Arms (2)

Amnion Membrane Powder

EXPERIMENTAL

amnion membrane power applied during MOHS scalp surgery

Drug: Amnion Membrane Powder

Standard of Care

ACTIVE COMPARATOR

aquaphor ointment applied during MOHS scalp surgery

Drug: Standard of Care

Interventions

Amnion Membrane PowderDRUG

amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery

Amnion Membrane Powder
Standard of CareDRUG

aquaphor ointment applied during MOHS scalp surgery

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Christine Ahn, MD

    Atrium Health Wake Forest Baptist

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary-Clare Day

CONTACT

336-713-1343Maryclare.Day@advocatehealth.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)