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Amnion Wound Covering for Enhanced Wound Healing
Phase < 1
Waitlist Available
Led By Joseph Molnar, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 26 weeks
Awards & highlights
Study Summary
This trial will test if a powder made from amniotic membrane can safely be used to cover wounds and improve the condition of skin graft donor sites.
Eligible Conditions
- Skin Wound
- Burns
- Dermabrasion
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 26 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Donor Site Wound Closure
Secondary outcome measures
Injury wounds
Dermatitis
Presence of infection
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Amnion membrane product treatment areaExperimental Treatment2 Interventions
The prepared amnion membrane powder will be directly applied to the prepared donor wound site (Site A). The wound will then be covered with the SOC dressing.
Group II: SOC Wound Covering treatment areaActive Control1 Intervention
The donor wound site (Site B) will be covered per SOC (Standard of care).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Amnion Membrane Powder
2019
Completed Early Phase 1
~10
SOC Wound Covering
2019
Completed Early Phase 1
~10
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,176 Total Patients Enrolled
Joseph Molnar, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
2 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been taking antibiotics for more than 48 hours before the grafting procedure.
Research Study Groups:
This trial has the following groups:- Group 1: Amnion membrane product treatment area
- Group 2: SOC Wound Covering treatment area
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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