Clinical trial NCT03754218: Amnion Wound Covering for Enhanced Wound Healing
Official title: Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Burns
Wound of Skin
Skin Wound
Keywords: Human amnion membrane
Autologous skin graft
Scar Formation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of Donor Site Wound Closure
timeFrame: Week 4
Secondary outcomes:
measure: Incidence of Donor Site Wound Healing
timeFrame: week 12
measure: Presence of infection
timeFrame: up to 26 Weeks
measure: Vancouver Scar Assessment Scale
timeFrame: up to 26 Weeks
measure: Presence of Dermatitis
timeFrame: Up to 26 Weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Joseph Molnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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