Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of… (NCT05462860) | Clinical Trial Compass
RecruitingNot Applicable
Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
United States21 participantsStarted 2024-09-18
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 admission per Investigator or treating physician discretion
* Pregnancy/lactation
* Subjects who are unable to follow the protocol or who are likely to be non-compliant
* Participation in an active treatment arm of a burn wound related interventional study within 90 days of Screening Visit or during the study
* Prisoners
* Life expectancy less than 6 months
* Subjects who are receiving steroids, chronic anticoagulants, or immune suppressive treatment