Amnion Membrane Powder Mohs Study

Starting soon · Phase 1

Conditions studied: Wound Heal

In brief

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.

Key facts

Study ID

NCT07680023

Run by

Wake Forest University Health Sciences

People needed

20

Starts

2026-10-01

Expected to finish

2027-10-01

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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