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This study is designed as a prospective, randomized, within subject controlled design to evaluate the effectiveness of Microsurfaced vs Control cadaveric grafts for coverage of acute deep-partial or full-thickness burn wounds to promote wound healing. This study will be performed in 2 parts: Time to wound bed preparedness through 6 weeks (Part A) and wound site healing, graft take and long-term scar outcomes (Part B). Subjects will be treated with both control and microsurfaced cadaveric grafts on adjacent deep-partial or full-thickness burn wounds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Dermal Graft | Active Comparator | Standard of care cryopreserved cadaveric split thickness skin grafts |
|
| Standard of Care Dermal Graft - Microsurfaced | Experimental | Microsurfaced cryopreserved cadaveric split thickness skin grafts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Split thickness skin graft | Biological | standard of care graft |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wound bed prep | To compare wound bed preparedness/time to autograft in deep-partial and full thickness burns and burn wound healing in partial thickness burns in burn sites treated with Microsurfaced vs Control cadaveric graft-treated groups through 6 weeks post initial injury. | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Infection | Incidence of Infection at each treatment study visit | Through 12 months |
| Autograft take | Autograft take will be documented as a percentage of the graft by the physician |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joan Wilson | Contact | 706-364-2966 | joan.wilson@jmsreserachfoundation.org |
| Name | Affiliation | Role |
|---|---|---|
| Claus Brandigi, MD | Joseph M Still Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph M Still Research Foundation | Recruiting | Augusta | Georgia | 30909 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 14, 2025 | Apr 3, 2025 | 2 | ||
| Apr 11, 2025 |
| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| microsurfaced split thickness skin graft |
| Biological |
standard of care graft that has been microsurfaced |
|
| 2 weeks |
| Tissue oxygenation | Tissue oxygenation will be assessed using hyperspectral imaging | 2 weeks |
| Tissue Oxygenation | Change in tissue oxygenation at study burn site at the time of autografting as compared to baseline. | 6 weeks |
| Scar assessment | Scar will be assessed using the Patient and Observer Scar Assessment Scale (POSAS) | 3, 6, 9, 12 months |
| Tissue oxygenation | Tissue oxygenation will be assessed using hyperspectral imaging | 3, 6, 9, 12 months |
| May 1, 2025 |
| 3 |
| Aug 25, 2025 | Sep 9, 2025 | 4 |