Suprathel® Use During Prolonged Field Care to Promote Healing and Reduce the Need for Grafting of Burn Wounds
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Metis Foundation
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Suprathel®
Treatment groups
21 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov