The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns. The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound. In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment. Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
61
Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
Unfallkrankenhaus Berlin
Berlin, Germany
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil
Bochum, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Linköping University Hospital
Linköping, Sweden
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care
Photo-based evaluation by independent experts blinded to the treatment regime.
Time frame: 2 to 3 weeks
Intra-individual Difference in Time to Wound Closure Between Wound Halves, Either Treated With Oleogel-S10 or Treated With Standard of Care
Time frame: 2 to 3 weeks
Time From Study Start After Burn Accident Until Wound Closure is Achieved Separately for Wound Halves Treated With Oleogel-S10 vs. Standard of Care
Time frame: 2 to 3 weeks
Percentage of Patients With Wound Closure at Different Time Points
Time frame: 2 to 3 weeks
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
Time frame: 2 to 3 weeks
Likert Scale Rating of Efficacy (Evaluated by Both the Investigators and Patients)
By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to grade the efficacy of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Time frame: 2 to 3 weeks
Cosmetic Outcome After 3 and 12 Months After Burn Accident, in Relation to Texture, Redness, Growth of Hair and Pigmentation, Based on Blinded Photo Evaluation
Time frame: 3 and 12 months
Likert Scale Rating of Tolerance (Evaluated by Both the Investigators and Patients)
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University Hospital
Uppsala, Sweden
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Broomfield Hospital
Chelmsford, United Kingdom
Queen Victoria Hospital
East Grinstead, United Kingdom
By direct comparison of the separate simultaneous treatments for the two wound halves, patients and investigators, respectively, are asked to provide their opinion on the tolerance of Oleogel-S10 Versus Standard of Care on a questionnaire with a 5-point graded visual analogue scale
Time frame: 2 to 3 weeks
PK Data: Systemic Presence/Concentration of Betulin in Blood Plasma Samples
Time frame: 2 to 3 weeks
Microbial Colonization of the Wound Halves
Time frame: 2 to 3 weeks
Assessment of Adverse Events
Time frame: 2 to 3 weeks