Wound HealPhase 1NCT07680023
Amnion Membrane Powder Mohs Study
A Phase 1 study testing Amnion Membrane Powder in people with Wound Heal, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wound Heal
- What is being tested?
- Amnion Membrane Powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2027to Oct 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
Mary-Clare Day, 336-713-1343, maryclare.day@advocatehealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Wound Heal
- Being tested
- Amnion Membrane Powder, Standard of Care
- Keywords
- MOHS surgery, amnion membrane powder, scalp wound healing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion Membrane PowderDrug
amnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery
Standard of CareDrug
aquaphor ointment applied during MOHS scalp surgery
| Study group | Role | What they receive |
|---|---|---|
| Amnion Membrane Powder | Experimental | amnion membrane power applied during MOHS scalp surgery Receives: Drug: Amnion Membrane Powder |
| Standard of Care | Active comparator | aquaphor ointment applied during MOHS scalp surgery Receives: Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Infection
Number of participants that developed a wound infection
Measured: Through week 16
Number of Participants with Allergic Reaction
Number of participants with an allergic reaction to the intervention
Measured: Through week 16
Number of Treatment-Related Adverse Events
Number of treatment-related adverse events
Measured: Through week 16
Number of Unscheduled Visits for Wound Bleeding
Number of participants that had an unscheduled visit for wound bleeding
Measured: Through week 16
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Baseline
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 1
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 2
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 3
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 4
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 5
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 6
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 7
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 8
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 12
Pain Score
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Measured: Week 16
Secondary outcomes (3)
Time Until Wound Closure
Number of days until wound was completely closed
Measured: Through week 16
Time Until of Wound Closure
Number of days until wound was fully sealed
Measured: Through week 16
Percentage of Re-epithelialization
Percentage of the wound with re-epithelialization
Measured: Week 1, week 4, week 8, week 12, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study startMay 2027 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christine Ahn, MD, Principal investigator, Atrium Health Wake Forest Baptist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680023
- Sponsor's protocol ID
- IRB00151720
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Human Amnion Membrane Powder for Enhanced Wound Healing of Mohs Surgery Wound Sites
- ClinicalTrials.gov ID
- NCT07680023
- Acronym / sponsor ID
- IRB00151720
- Conditions
- Wound Heal
- Keywords
- MOHS surgery, amnion membrane powder, scalp wound healing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2027 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amnion Membrane Powder | Experimental | Drug: Amnion Membrane Powderamnion membrane power applied during MOHS scalp surgery |
| Standard of Care | Active comparator | Drug: Standard of Careaquaphor ointment applied during MOHS scalp surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amnion Membrane Powderamnion membrane power dose of 0.26 mg/mm3 applied during MOHS scalp surgery | Drug | Amnion Membrane Powder |
| Standard of Careaquaphor ointment applied during MOHS scalp surgery | Drug | Standard of Care |
Primary outcome
Number of Participants with Infection
Time frame: Through week 16
Number of participants that developed a wound infection
Number of Participants with Allergic Reaction
Time frame: Through week 16
Number of participants with an allergic reaction to the intervention
Number of Treatment-Related Adverse Events
Time frame: Through week 16
Number of treatment-related adverse events
Number of Unscheduled Visits for Wound Bleeding
Time frame: Through week 16
Number of participants that had an unscheduled visit for wound bleeding
Pain Score
Time frame: Baseline
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 1
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 2
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 3
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 4
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 5
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 6
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 7
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 8
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 12
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
Pain Score
Time frame: Week 16
Participants asked rate their pain on a scale of 1-10 with 10 being worst pain.
3 secondary outcomes
Time Until Wound Closure
Time frame: Through week 16
Time Until of Wound Closure
Time frame: Through week 16
Percentage of Re-epithelialization
Time frame: Week 1, week 4, week 8, week 12, week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christine Ahn, MD principal investigator
Atrium Health Wake Forest Baptist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Amnion Membrane Powder in people with Wound Heal, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary-Clare Day (336-713-1343, Maryclare.Day@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Infection (time frame: Through week 16). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.