Split-Thickness Skin Graft Donor Sites MedDRA version: 16.1 Level: LLT Classification code 10041667 Term: Split thickness skin graft System Organ Class: 100000004865
Conditions
Interventions
Product Name: Oleogel-S10
Pharmaceutical Form: Ointment
INN or Proposed INN: Dry extract from Betulae cortex (Birch cork) (5-10 : 1), quantification: 72 to 88 % Betulin, extraction solvent: n-Heptane
Sponsors
Birken AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients at least 18 years old who have provided written informed consent • Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 and with a minimum width of 3 cm. • Patient is able to understand the ICF provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every third or fourth day until both wound halves are closed (but no longer than 28 days after surgery). • Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits. • Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)). 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 57 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 48
Exclusion criteria
Exclusion criteria: • Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy. • 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, surgical dressings or excipients 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. • Pregnant or breast feeding women are not allowed to participate in the study. • Inappropriate to participate in the study, for any reason, in the opinion of the investigator. • Mental incapacity or language barriers precluding adequate understanding the Informed consent form or co-operation or willingness to follow study procedures. • Previous participation in this study. • Employee at the investigational site, relative or spouse of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare intra-individually the efficacy and tolerance of Oleogel-S10 versus non-adhesive wound dressing alone in accelerating the wound healing of Split-Thickness Skin Graft Donor Sites.;Secondary Objective: not applicable;Primary end point(s): Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, based on blinded photo evaluation by three independent, blinded experts. ;Timepoint(s) of evaluation of this end point: At every wound dressing change (at least every third or fourth day until full wound closure is achieved; no longer than 28 days after surgery) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): A) Intra-individual difference in time to wound closure (at least 95% epithelialisation) between wound halves either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing alone, separately for each of the three independent, blinded experts. B) Time from surgery until wound closure is achieved, separately for wound halves treated with Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing alone. C) Percentage of patients with earlier healing of wound area treated with Oleogel S10 compared to non-adhesive wound dressing alone. D) Percentage of patients with wound closure at different time points. E) Percentage of wound epithelialization at different time points as assessed by a study team member during wound dressing change. F) Assessment of efficacy (evaluated by both the investigators and patients). G) Cosmetic outcome after 3 and 12 months after surgery with regard to texture, redness, growth of hair, and pigmentation, based on blinded photo evaluation. H) Assessment of tolerance (evaluated by both the investigators and patients). I) PK data: Systemic presence/concentration of betulin in blood plasma samples. J) Assessment of adverse events. ;Timepoint(s) of evaluation of this end point: A) to E), J): At every wound dressing change (at least every third or fourth day until full wound closure is achieved; no longer than 28 days after surgery) F): Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before G): 3 and 12 months after surgery H): Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before I): Days 7, 14, 21, 28 (each +/- 1 day); only if wound closure did not occur before | — |
Countries
Austria, Bulgaria, Czech Republic, Finland, Germany, Poland
Contacts
Public ContactBusiness Unit Pharma
Birken AG
Outcome results
None listed