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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-RC220169 | Other Grant/Funding Number | Congressionally Directed Medical Research Program | |
| E04634.1a | Other Identifier | Office of Human and Animal Research Oversight |
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| Name | Class |
|---|---|
| The University of Texas Medical Branch, Galveston | OTHER |
| United States Department of Defense | FED |
| United States Army Institute of Surgical Research | FED |
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This is a prospective, randomized, controlled, multi-center clinical study comparing SupraSDRM® to standard of care wound dressing, BTM, in the treatment of full-thickness wounds deemed not immediately suitable for definitive grafting will be performed.
Twenty-four patients with full-thickness wounds fulfilling inclusion criteria of the study will be consented and enrolled into the clinical trial. An area (≥ 5 and ≤125 cm2) deemed not immediately ready to accept skin graft will be designated as the study site. The study site will be randomized to receive either SupraSDRM® or the SoC wound dressing, NovoSorb® BTM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SupraSDRM® | Experimental | Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings. |
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| SOC Skin Substitute | Active Comparator | Once randomization is completed and the site is adequately debrided the assigned treatment dressing will be applied according to their respective instructions for use. Supplemental supportive dressings including negative pressure treatment may be used in conjunction with the study dressings. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SupraSDRM® | Device | SupraSDRM® Bidegradable Matrix Wound Dressing is a tri-polymber, Biodegrable dermal covering manufactured by PolyMedics Innovations, GmbH. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of days between the application of the dermal substitute to when the dermal substitute is deemed suitable for grafting by the treatment care team. | This endpoint is based on the ability of the dermal substitute to rapidly vascularize and allow for placement of a skin graft. | up to 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical incidence of skin substitute infection | Incidence of infections and inflammatory response and scar development | up to 5 weeks |
| Days of skin graft application from time of SupraSDRM® or SoC application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria Diaz, RN | Contact | 2105691140 | Diaz@metisfoundationusa.org | |
| Kristin Anselmo | Contact | kanselmo@metisfoundationusa.org |
| Name | Affiliation | Role |
|---|---|---|
| Rodney Chan, MD | Metis Foundation | Principal Investigator |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| D002056 | Burns |
| D000081084 | Accidental Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| NovoSorb® BTM | Device | NovoSorb® BTM absorbable synthetic wound dressing, PolyNovo Biomaterials, K172140 |
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The wounds will be assessed for their readiness for grafting by their treating surgeon at minimum weekly
| up to 5 weeks |
| Percentage graft survival as assessed 7 days after skin graft application | Percent of graft survival will be measured by clinical assessment | 7 days |
| Number of return trips to the OR | The wounds will be assessed by their care team as part of standard care procedures. Research personal will document any areas of concern or additional surgeries required. | up to 1 year |
| Skin graft contraction | Patient and Observer Scar Assessment Scale (POSAS) Questionnaire will be used to assess scaring and contraction. This scale uses a 1-10 rating scale with 1 being normal and 10 being worst imaginable outcome. | up to 1 year |
| Wound Pain scale 1-10 | Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) at each visit | up to 1 year |
| Cost-effectiveness | looking at the overall length of stay in the hospital, the number of trips to the operating room and cost of skin substitute will help determine if the study dressing is more or less cost affective | up to 1 year |