Amnion Membrane Powder for Wound Healing

MD
Overseen ByMary-Clare Day
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Wake Forest University Health Sciences
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?

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.

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
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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+