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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Suprathel®
Other interventionApplication of standard of care dressing.®
Treatment groups
21 Participants
are divided into 2 treatment groupsGroup A: Suprathel® dressingExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
21 daysSecondary outcomes
1
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)2
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)3
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 weeklySponsors and contacts
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Source ClinicalTrials.gov