Burns Clinical Trial
Official title:
Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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