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This study will evaluate the efficacy of a dehydrated human placental tissue product, commercially labeled as AmCoreMatrix Burn â„¢ versus SOC in the closure of partial thickness burns. Human Cellular and Tissue based Products (HCT/Ps), specifically Dehydrated Human Amnion - Intermediate Layer - Chorion Membrane (dHAICM) offer a multimodal biological approach to burn management. Unlike synthetic dressings or silver-based creams, dHAICM serves as a sophisticated bioactive scaffold. It is a minimally manipulated allograft that provides superior tensile strength and barrier function compared to single-layer membranes. This study aims to document its performance in hospital burn units.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. |
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| AIC and Standard of Care | Experimental | Participants with a thermal burn classified as either superficial partial thickness or deep partial thickness will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 10 weeks, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amnion-Intermediate-Chorion | Other | Dehydrated human placental multilayer allograft derived from donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Complete Epithelialization | Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance. | 1-10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Burn Area Change | To evaluate the difference in percentage reduction in burn wound area at each follow-up visit in participants receiving dHAICM versus SOC alone. | 1-10 weeks |
| Frequency of Full Epithelialization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bryanna Finstein | Contact | 6035574660 | bryanna.f@cellutionbiologics.com | |
| Cellution Research | Contact | 6035574660 | clinical@cellutionbiologics.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Cellution Biologics | Study Director |
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| Standard of Care (SOC) | Procedure | Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance. |
|
To compare the frequency of full epithelialization at 3 weeks in participants receiving dHAICM versus SOC alone.
| 1-10 weeks |
| Changes in Pain Scores Associated with Target Burns | To determine the reduction in pain scores (VAS) for participants during dressing changes. | 1-10 weeks |
| Changes in Scarring Quality of Target Burn | To determine the difference in assessment of scarring quality using the Vancouver Scar Scale (VSS). | 1-10 weeks |
| Incidents of Adverse Events | To determine the difference in the frequency and nature of adverse events in participants receiving dHAICM versus SOC alone. | 1-10 weeks |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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