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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Application of standard of care dressing.®
North Carolina Jaycee Burn Center
Chapel Hill, North Carolina, United States
RECRUITINGNeed 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.
Time frame: 21 days
Wound infection rate, wound closure of the region
Incidence of infections and inflammatory response and scar development
Time frame: 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).
Patient and Observer Scar Assessment Scale (POSAS) Questionnaire is used to assess scarring.
Time frame: 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.
Time frame: After initial application (Day 0) and weekly
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