Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
The Metis Foundation
Summary
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.
Description
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…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or Female ≥18 years and ≤75 years * Acute partial thickness burns by friction, contact, scalding from hot liquids and flame * TBSA total ≥2 %; burn treatment region of interest: all areas with partial-thickness burns excluding face, neck, scalp, and feet * TBSA 3rd ≤5 % (not to be included as burn treatment region of interest) * Subject is able and willing to sign Informed Consent or via legally authorized representative Exclusion Criteria: * Study Wound due to electrical, radioactive, or frostbite-related injury * Infection of wounds in the study area at admissio…
Interventions
- OtherSuprathel®
Application of standard of care dressing.®
Location
- North Carolina Jaycee Burn CenterChapel Hill, North Carolina