Amnion Membrane Powder for Wound Healing

MD
Overseen ByMary-Clare Day
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called amnion membrane powder to determine if it improves wound healing after Mohs surgery on the scalp. Mohs surgery is a precise technique for removing skin cancer. The study aims to assess the safety of using the powder on deep wounds that are at least 4 square centimeters. Participants should undergo Mohs surgery on their scalp, have a wound meeting these criteria, and be prepared to follow the study's care and follow-up instructions. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that amnion membrane powder is likely to be safe for humans?

Research has shown that amnion membrane powder is generally safe for healing wounds. One study found it safe and helpful for covering wounds, especially compared to regular ointments. Another study noted that using the amnion membrane after surgery is a simple and well-tolerated way to treat wounds. Additionally, research on similar products, like the amnion-chorion membrane, has shown that most wounds treated with these materials stay closed, proving their effectiveness and safety. Overall, these findings suggest that amnion membrane powder is a promising and safe option for improving wound healing.12345

Why do researchers think this study treatment might be promising?

Unlike the standard of care for wound healing, which often involves topical ointments like Aquaphor, Amnion Membrane Powder is derived from the innermost layer of the placenta. Researchers are excited about this treatment because it introduces a new mechanism of action by using the natural regenerative properties found in amniotic tissue, which may accelerate healing. This powder has the potential to enhance tissue repair and reduce scarring, offering a promising alternative to traditional ointments.

What evidence suggests that amnion membrane powder might be an effective treatment for wound healing?

Research has shown that amnion membrane powder holds promise for healing wounds. In this trial, participants will receive either amnion membrane powder or standard care with aquaphor ointment during Mohs scalp surgery. Studies have found that amnion membrane powder helps wounds close faster and improves their appearance after surgery. Specifically, one study showed that wounds treated with amnion membrane healed more quickly than those treated with traditional methods. Another study found that up to 94.4% of wounds treated with this powder stayed closed over time. This treatment encourages new tissue growth, promoting quick and effective wound healing.14567

Who Is on the Research Team?

CA

Christine Ahn, MD

Principal Investigator

Atrium Health Wake Forest Baptist

Are You a Good Fit for This Trial?

This trial is for people having Mohs surgery on their scalp to remove skin cancer. Participants should be adults who are able to follow study instructions and attend follow-up visits.

Inclusion Criteria

Subject agrees to abstain from any other covering or treatment of the wound(s) during the study unless directed by study surgeon or surrogate
Subject and/or guardian can read, understand instructions, and give informed, voluntary, written consent
Subject is able and willing to follow protocol requirements
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Exclusion Criteria

I have invasive melanoma or high-risk squamous cell carcinoma needing radiation therapy.
Hemoglobin <10.0 or >19.0 g/dL
Known hypersensitivity to Compound Sodium Lactate for Irrigation (Hartmann's) solution
See 14 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Amnion membrane powder or standard care ointment is applied during Mohs scalp surgery

Immediate application during surgery

Follow-up

Participants are monitored for safety and effectiveness, including infection, allergic reactions, and wound healing progress

16 weeks
Regular visits at week 1, week 4, week 8, week 12, and week 16

What Are the Treatments Tested in This Trial?

Interventions

  • Amnion Membrane Powder

Trial Overview

The study compares the use of amnion membrane powder with standard wound care after Mohs surgery, to see if it helps wounds heal better and faster. Patients are randomly assigned to either treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Amnion Membrane PowderExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34237012/

A Preliminary Study Assessing Wound Closure Rate

The cosmetic outcome and time to wound closure appeared to be improved in patients treated with ATDA when compared with expected outcomes.

NCT07680023 | Amnion Membrane Powder Mohs Study

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 ...

Use of Amniotic Tissue–Derived Allografts Post-Mohs ...

The data presented in this study show that ATDA is effective in healing wounds by secondary intention post-Mohs micrographic surgery and may increase wound ...

Amnion membrane hydrogel and amnion membrane powder ...

We found that the amnion hydrogel and amnion powder treatments demonstrated significant and rapid wound healing, driven primarily by new ...

Placental Allograft Reconstruction of Cutaneous Wounds ...

Methods: This study was a 5-year retrospective, analysis comparing propensity-matched cohorts of eligible Mohs surgery patients treated with a placental ...

Amnion membrane hydrogel and amnion membrane powder ...

The results indicated that amnion membrane is safe and advantageous for wound coverage compared with the standard topical ointments.

Post-Mohs Surgical Defect Repair with Dehydrated Human ...

This data suggests that biological amnion may be a minimally invasive clinical option, allowing physicians to have a post-MMS standard of care.