Could a Placenta-Derived powder revolutionize wound healing after skin cancer surgery?
NCT ID NCT07680023
First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This phase 1 trial tests whether a powder made from human amnion membrane is safe and can improve healing of scalp wounds after Mohs surgery for skin cancer. About 20 adults with scalp wounds at least 4 cm² will receive either the amnion powder or standard ointment. Researchers will track infections, allergic reactions, pain, and how quickly the wound closes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- amnion membrane powder
- What this could lead to
- If safe and effective, this powder could speed up healing and reduce pain after Mohs surgery on the scalp.
- What could go wrong
- This is a very early, small phase 1 safety study with only 20 people. It may not show clear benefit, and risks like infection or allergic reaction are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
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