Accelerating the Epithelialization of Split Thickness Skin Graft Clinical Trial
Official title:
Open, Prospective, Controlled, Randomised, Multicenter Phase II Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Moist Wound Healing Dressing Alone in Accelerating the Epithelialization of Split Thickness Skin Graft Donor Sites
In this study the wound reepithelialization of that part of the skin graft donor site, which is treated with Oleogel-S10 compared to that part of the wound, which is covered by moist wound healing dressing alone will be investigated.
As a first step, an adequate size of the wound healing dressing (Mepilex) is taken and cut
in half. Then, half of the SSG (split skin graft) wound is covered conventionally by
applying one half of the Mepilex cut. Afterwards Oleogel-S10 is applied to the other half of
the Mepilex cut, which is used to cover the other half of the SSG wound. Both parts of the
Mepilex dressings are then covered by an additional conventional dressing.
Oleogel-S10 is always applied to the same part of the SSG wound for each patient,
respectively, depending on the randomization of the patient, either towards the periphery of
the body, i.e. the lower part of the leg, or towards the centre part of the body, i.e. the
upper part of the leg. In order to avoid a confusion about which part has to be treated with
Oleogel-S10, the healthy skin next to the SSG wound will be marked with ink for indication
of the Oleogel-treated part of the wound.
Each day during the treatment period, whenever the wound dressing is changed, a clinical
examination and assessment of the progress of epithelialization of the SSG wound will be
conducted, including evaluation of tolerance, and photos of the wound without dressing will
be taken.
A blinded assessment of the efficacy is conducted by two independent investigators using the
macro-photos of every day, when wound dressings were changed, and a final examination is
done. In this assessment, the third part of the SSG wound that is in between the left and
right parts is neglected.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment