Accelerating the Epithelialization of Split Thickness Skin Graft Clinical Trial
— OleoSplitOfficial 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
Verified date | April 2015 |
Source | Birken AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 95 Years |
Eligibility |
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 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. Exclusion Criteria: 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Universitäts-Hautklinik Freiburg | Freiburg | |
Germany | Universitätsklinikum der Ernst-Moritz-Arndt-Universität Greifswald | Greifswald |
Lead Sponsor | Collaborator |
---|---|
Birken AG |
Germany,
Metelmann HR, Brandner JM, Schumann H, Bross F, Fimmers R, Böttger K, Scheffler A, Podmelle F. Accelerated reepithelialization by triterpenes: proof of concept in the healing of surgical skin lesions. Skin Pharmacol Physiol. 2015;28(1):1-11. doi: 10.1159/ — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 14 days | Yes | |
Secondary | • Size of wound epithelialization | 3 months | No | |
Secondary | • 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" | 3 months | Yes | |
Secondary | • Pruritus (visual analogue scale from "no" = 0 to "strong" = "10") | 3 months | Yes | |
Secondary | • Reconstitution of the skin (% reepithelization) 3 months after skin explantation | Evaluation of wound closure by assessment of epithelialization (in %) | 3 months | No |