Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
EARLY_PHASE1
Total Enrollment
7 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-12-01
Study Completion Date
2023-11-22
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.
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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.
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.
Conditions
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Burns
Wound of Skin
Skin Wound
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
EXPERIMENTAL
Amnion Membrane Powder
Intervention Type
DRUG
This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
SOC Wound Covering
Intervention Type
PROCEDURE
Institutional standard of care wound covering.
SOC Wound Covering treatment area
The donor wound site (Site B) will be covered per SOC (Standard of care).
Group Type
ACTIVE_COMPARATOR
SOC Wound Covering
Intervention Type
PROCEDURE
Institutional standard of care wound covering.
Interventions
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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.
Intervention Type
DRUG
SOC Wound Covering
Institutional standard of care wound covering.
Intervention Type
PROCEDURE
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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Joseph Molnar, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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IRB00054157
Identifier Type: -
Identifier Source: org_study_id
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