Wounds 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 Wound Healing of Split-Thickness Skin Graft Donor Sites
The main purpose of this phase III clinical trial was to show safety and efficacy of Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in
participants with skin lesions. Especially the results in a previous study with STSG donor
sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of
superficial wounds.
The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound
healing progress, i.e., the time to healing and the grade of epithelialization of the wound.
In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1
wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half
with non-adhesive wound dressing only (standard of care).
Wound healing progress was documented by photos which were assessed by expert reviewers
blinded to the treatment of the wound halves.
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