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 (OleoSplit)
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|ClinicalTrials.gov Identifier: NCT01294254|
Recruitment Status : Completed
First Posted : February 11, 2011
Last Update Posted : April 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Accelerating the Epithelialization of Split Thickness Skin Graft||Drug: Oleogel-S10 Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||April 2010|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
Experimental: experimantal: wound site will be treated with Oleogel-S10
The patients will be randomised in a ratio of 1:1 with regard to the part of the skin graft donor site that is treated with Oleogel-S10.
Arm A: application of Oleogel-S10 towards the periphery of the body, i.e. the lower part of the leg
Arm B: application of Oleogel-S10 towards the centre part of the body, i.e. the upper part of the leg
Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily)
Active Comparator: Moist wound healing dressing alone
Treatment with moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
Procedure: Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site
wound is covered conventionally by applying one half of the Mepilex cut
- 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 during a treatment period of 14 days. [ Time Frame: 14 days ]
- • Size of wound epithelialization [ Time Frame: 3 months ]
- • Touch sensitivity: Sensitivity of the SSG wound by touching it with a spatula or cotton swabs (visual analogue scale from "no" = 0 to "severe" = "10" [ Time Frame: 3 months ]
- • Pruritus (visual analogue scale from "no" = 0 to "strong" = "10") [ Time Frame: 3 months ]
- • Reconstitution of the skin (% reepithelization) 3 months after skin explantation [ Time Frame: 3 months ]Evaluation of wound closure by assessment of epithelialization (in %)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01294254
|Freiburg, Germany, 79104|
|Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald|
|Greifswald, Germany, 17475|
|Principal Investigator:||Hans Robert Metelmann, Prof. Dr. med.||University Hospital of Ernst-Moritz-Arndt-University Greifswald|