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 SitesOleoSplit-Trial - OleoSplit-Trial

Birken GmbH0 个研究点目标入组 80 人开始时间: 2010年1月12日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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 or sterilization) during treatment and for at least 6 months thereafter.
•Men must agree to use an effective method of contraception during treatment and for at least 6 months thereafter.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients will be excluded from the study if they have/are:
•burns involving more than 15% of their total body area;
•sepsis, haemodynamic instability requiring pressor support or positive blood microbiology cultures within 48h of surgery;
•inhalation injury requiring artificial respiratory assistance;
•requiring skin grafts following removal of suspicious skin lesions;
•received treatment with systemic steroids during the 30 days prior to surgery;
•uncontrolled diabetes or diabetic ulcers;
•diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerance or efficacy;
•previously skin grafts harvested from the area to be studied;
•a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial;
•a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial;
•known multiple allergic disorders;
•taking, or have taken, any investigational drugs within 3 months prior to the screening visit;
•undergoing investigations or changes in management for an existing medical condition;
•not likely to complete the trial for whatever reason.

发起方

Birken GmbH