Amnion Wound Covering for Enhanced Wound Healing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Burns, Wound of Skin, Skin Wound

Intervention / Treatment
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* Drug: Amnion Membrane Powder
* Procedure: SOC Wound Covering


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Donor Site Wound Closure | 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 | 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 | 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 | 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 | Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis. | Up to 26 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human amnion membrane, Autologous skin graft, Scar Formation