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

INTERVENTION: Product Name: Oleogel ‐ S 10 Pharmaceutical Form: Cutaneous suspension INN or Proposed INN: Triterpene dry extract from birk cork Current Sponsor code: TE Concentration unit: % percent Concentration type: equal Concentration number: 10‐ CONDITION: Es handelt sich um eine offene, prospektive, kontrollierte, randomisierte, multizentrische Studie der Phase II, die eine intra‐individuelle Wirksamkeit und Verträglichkeit des Oleogel‐S10 mit einer feuchten Wundauflage im Hinblick auf einen Beschleunigung der Epithelialisierung der Wunde nach der Entnahme von Spalthaut mit einander vergleicht. PRIMARY OUTCOME: Main Objective: Wound reepithelialization of that part of the skin graft donor site, which is treated with Olegel‐S10 compared to that part of the wound, which is covered by moist wound healing dressing alone during a treatment period of 14 days. Primary end point(s): The primary endpoint for the biometrical evaluation of the therapy is wound re‐epithelialization of that part of the skin graft donor site, which is treated with Olegel‐S10 (about 50% of the total wound size) compared to that part, which is covered by moist wound healing dressing alone. A blinded assessment of the efficacy is conducted by two independent experts using the macro‐photographs of every day, when wound dressings were changed, and a final examination at day 14. In all assessments, the third part of the SSG wound that is in between the left and right parts is neglected. ; The decision which part of the SSG wound is more epithelialized than the other will be made by the two independent experts at each time point respectively. The more epithelialized part will be assigned a “1”, the other part a “0”. The experts assessing the progress of the wound epithelialization do not know which part has been treated with Oleogel‐S10.; In case the experts assign different results to a particular SSG wound, that assessment is not counted. Otherwise one gets a “0/1” result for each part of the wound at each time point, respectively. At the end of the investigation a total score will be calculated by summing the 0/1‐scores for each time point and for each part of the wound, respectively.; The higher total score for each SSG wound will give the final “winner” of the wound closure progress, either Oleogel‐S10 or the wound dressing alone.; Secondary Objective: • Size of wound epithelialization; • Touch sensitivity; • Pruritus; • Reconstitution of the skin 3 months after skin explantation; INCLUSION CRITERIA: Patients may participate in the study if they have/are: •Patients aged 18‐95 years who have provided written informed consent. •Patients requiring skin grafting due to burns, trauma, chronic venous ulcers, or surgical removal of cutaneous malignancies with a donor site expected to be between 8 and 200 cm2 on a non‐articulated area. •Patient is prepared to comply with all study requirements, including the following: ‐ Application of Oleogel‐S10 on the SSG at every change of wound dressing; ‐ Regular clinic visits during the treatment period, and follow‐up period. •Negative pregnancy test of women of childbearing potential performed within 7 days prior to the start of treatment. •Women of childbearing potential must agree to use an effective method of contraception (Pearl‐Index < 1, e.g. hormonal contraception including the combined oral contraceptive pill, the transdermal patch, and the contraceptive vaginal ring, intrauterine devices