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| ID | Type | Description | Link |
|---|---|---|---|
| CDMRP-MB200024 | Other Grant/Funding Number | Congressionally Directed Medical Research Program Office |
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The purpose of this study is to determine the effect to which Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany) can reduce the need for grafting compared to Standard of Care (SoC). Furthermore, the study intends to evaluate if Suprathel® allows for a reduction of reduction of pain, infection, provider workload, scar development and costs compared to SoC.
We are advocating the study of Suprathel® (Polymedics Innovations GmbH, Denkendorf, Germany), a synthetic wound dressing made of polymers of D-,L- lactate, and ε caprolactone, in the early coverage of burns for use in Large Scale Combat Operations (LSCOs) as compared to standard of care. The rationale for studying Suprathel® is its favorable physical characteristics as a portable treatment, ease of application by personnel without formal medical training, proven efficacy in improving outcomes after partial-thickness burn injury to include better pain control, preliminary evidence in decreasing burn wound conversion, and the lack of adverse consequences in covering indeterminant depth or full thickness burns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suprathel® dressing | Experimental | The Suprathel® dressing will be applied to the wound site after standard of care cleaning and debridement. The dressing will be maintained according to the manufacturer's instructions for use |
|
| Standard of Care | Active Comparator | The Standard of care as prescribed will be followed for the dressing application for the wound site. Dressings will be applied to the wound site after standard of care cleaning and debridement. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suprathel® | Other | Application of standard of care dressing.® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Need for autograft application | The reduction of need for grafting measured by the percentage of subjects who are converting to grafting at 21 ± 3 days after application. | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Wound infection rate, wound closure of the region | Incidence of infections and inflammatory response and scar development | 2 weeks, 3 weeks, and 6 weeks after application (without drainage or dressing requirements confirmed at two consecutive study visits 2 weeks apart) |
| Mid and long term clinical scar maturation assessed by the Patient and Observer Scar Assessment Scale (POSAS). |
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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 | Anselmo@metisfoundationusa.org |
| Name | Affiliation | Role |
|---|---|---|
| Rodney Chan, MD | Metis Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Carolina Jaycee Burn Center | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C527789 | poly(lactide-co-trimethylenecarbonate-co-epsilon-caprolactone) |
| 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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Proof of concept
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Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring. |
| Mid (3-9 months) and long term (52 weeks) |
| Patient-reported perception of pain based on the Visual Analog Scale | Patients will be asked to rate their pain 0-10 (0=no pain and 10=a lot of pain) prior to and after application of the first dressing and subsequent dressings. | After initial application (Day 0) and weekly |