Burns Clinical Trial
Official title:
Phase 1 Study of Human Amnion Membrane Powder for Enhanced Wound Healing
Verified date | May 2023 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | November 22, 2023 |
Est. primary completion date | November 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest University Health Sciences | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
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* Note: There are 40 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Presence of Dermatitis | Allergic Response to Human Amnion Membrane Product Covering will be assessed clinically by the presence of dermatitis. | Up to 26 Weeks |
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