Amnion Wound Covering for Enhanced Wound Healing

January 5, 2024 updated by: Wake Forest University Health Sciences

Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing

The purpose of this research study is to find our if human amnion membrane powder can be safely used as a covering for wounds and can improve the condition of skin graft donor sites. The amnion powder product is composed of "lyophilized" (freeze-dried), "gamma irradiation sterilized" (exposed to bacteria killing radiation) fragments of amniotic membrane.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Extensive burns and full thickness skin wounds can be devastating to patients, even when treated with our current standard of care. There are an estimated 500,000 burns treated in the United States each year. Moreover, in the military environment, soldiers who suffer from extensive burn injuries on the battlefield may benefit from rapid treatments that result in complete closure and protection of the wounds. As such, there is a need for mobile platform technologies that allow fast treatment at the site where the injury occurred, or at the very least at the forward operating sites. This safety investigation of a human amnion membrane powder product for wound healing is a with-in patient-controlled study, enrolling 10 subjects undergoing donor skin graft harvest. The single-center study will include patients undergoing donor skin harvest such that two regions, of at least 25 cm2 and separated by at least a 5 cm gap, of donor site wounds in comparable skin locations, are available for covering with the amnion membrane product and the current institutional standard of care (SOC) covering. 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.

The primary objective of the study is to evaluate the safety of a human amnion membrane product intended for enhanced wound healing. The secondary objective is efficacy as evidenced by complete wound closure relative to standard of care (SOC) treatment in a similar wound on the same subject at donor sites created for skin grafts at 14 days and 28 days postoperatively.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The subject requires autologous primary skin graft with two donor sites in similar areas, each measuring at least 25 cm2 with the likely depth of 0.012 inches and separated by a 5 cm gap. It is preferable that the two sites be on right and left sides of the body, but it is not an exclusion if they must be on the same side.
  • Eligible primary wound sites may be traumatic or chronic, and will be at least 50 cm2 (that will receive the donor graft) to allow assessment of two separate experimental donor sites of 25 cm2.
  • The subject is between the ages of 18 and 85 years of age.
  • 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 medically necessary.
  • 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 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 primary wound site is less than 50 cm2The subject's primary wound site is not deemed appropriate for skin graft based upon the investigator's clinical experience
  • 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.
  • 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 end-stage renal disease.
  • Hemoglobin <10.0 or >19.0 g/dL
  • Known 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 wound healing including but not limited to: current malignancy, uncontrolled diabetes (HbA1c >8) or diabetic ulcers, autoimmune disease or other immunocompromised diseases, renal impairment or ESRD, liver disease, hematological

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amnion membrane product treatment area
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.
Drug: Amnion Membrane Powder
This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
Procedure: SOC Wound Covering
Institutional standard of care wound covering.
Active Comparator: SOC Wound Covering treatment area
The donor wound site (Site B) will be covered per SOC (Standard of care).
Procedure: SOC Wound Covering
Institutional standard of care wound covering.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Donor Site Wound Closure
Time Frame: Week 4
Wound closure for both amnion membrane product and SOC will be defined as skin re-epithelization without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Donor Site Wound Healing
Time Frame: week 12
Wound Healing for both amnion membrane product and SOC will be assessed clinically confirmed at two consecutive study visits 2 weeks apart.
week 12
Presence of infection
Time Frame: up to 26 Weeks
The presence of infection will be evaluated in accordance with guidelines derived from Cutting and Harding using standard clinical measures.
up to 26 Weeks
Vancouver Scar Assessment Scale
Time Frame: up to 26 Weeks
Scar formation will be evaluated the Vancouver Scar Assessment Scale.The scale is composed by the following Sub scales (minimum and maximum ranges in parenthesis): Pigmentation (0-2), Vascularity (0-3), Pliability (0-5), Height (0-3). Total score 0-13. Lower score denotes better outcomes for total range and subscales.
up to 26 Weeks
Presence of Dermatitis
Time Frame: Up to 26 Weeks
Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis.
Up to 26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Joseph Molnar, MD, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

November 22, 2023

Study Completion (Actual)

November 22, 2023

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00054157

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Burns

Clinical Trials on Amnion Membrane Powder

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe