All burns of grade II to III
Conditions
Interventions
Group 1: Intervention group (Arm 1):
Application of the synthetic skin substitute SupraSDRM® following enzymatic debridement in patients with deep burn wounds (grade II–III). Subsequent standardized w
Sponsors
PolyMedics Innovations GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients aged over 18 years - ABSI (Abbreviated Burn Severity Index) score below 9 - Deep dermal burns (grade 2b) with focal areas of third-degree burns - Confirmation of burn depth by Laser Doppler Imaging (LDI) - Absence of severe comorbidities such as advanced heart failure or renal failure - Stable hemodynamic parameters (blood pressure, heart rate) - Notification of refusal of study participation by the patient’s legal guardian
Exclusion criteria
Exclusion criteria: - Severe comorbidities such as unstable cardiovascular diseases, severe renal insufficiency, or hepatic disorders that could compromise participation in the study. - Multimorbid patients whose condition could interfere with safe participation in the study. - Pregnant women, as the effects of the treatment on the fetus are not sufficiently known. - Patients with severe psychiatric disorders or cognitive impairments that may affect their ability to understand and comply with the treatment or study protocols. - Known allergies or hypersensitivity to components of the investigated wound closure matrices. - Insufficient compliance or cooperation of the patient or their legal representative to participate in the study. - Participation in other clinical trials that could potentially influence the results of the present study. - Patients with isolated second-degree (2a) or third-degree burns. - Withdrawal of consent or notification of discontinuation of the patient’s participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete wound healing (defined as full epithelialization without exudation) | — |
Secondary
| Measure | Time frame |
|---|---|
| Requirement for secondary autologous skin grafting Rate of wound infections Incidence of wound healing disorders Length of hospital stay Scar quality (e.g., assessed using validated scores such as the Vancouver Scar Scale) Pain progression during the treatment period | — |
Countries
Germany
Contacts
Public ContactJessica Strauch
Klinikum Nürnberg Süd
Outcome results
None listed