The main purpose of this phase III clinical trial was to compare intra-individually the efficacy, safety and tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor sites.
Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds. The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound. In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care). Wound healing progress was documented by photos which were assessed by expert reviewers blind to the treatment of the wound halves.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
107
1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.
Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.
Medical University of Graz
Graz, Austria
Intra-individual Difference in Time to Wound Closure
Intra-individual difference in time to wound closure between wound halves, either treated with Oleogel-S10 and non-adhesive wound dressing or treated with non-adhesive wound dressing only. Independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound half that were taken before start of treatment, during wound dressing changes and at the end of treatment. Difference in time to wound closure was calculated for every individual participant as \[time taken for wound half treated with Oleogel-S10 to close\] - \[time taken for wound half treated with non-adhesive wound dressing to close\], i.e., results below 0 indicate earlier wound closure of Oleogel-S10 treatment. The overall mean difference in time to wound closure was calculated based on all mean differences in time to wound closure of individual participants. Hence, primary outcome data derived from mean difference in time to wound closure by participant.
Time frame: up to 4 weeks
Time From Surgery Until Wound Closure is Achieved
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 only. While outcome measure 1 (intra-individual difference in time to wound closure) was calculated based on mean intra-individual difference in time to wound closure in 107 participants with missing values replaced by a value of 0, for outcome measure 2 missing values were not replaced. For 5 of the 107 wounds data were missing, thus the reported values are calculated from 102 STSG donor site wound halves by intervention (Oleogel-S10 and non-adhesive wound dressing vs. non-adhesive wound dressing only).
Time frame: up to 4 weeks
Percentage of Participants With Earlier Healing
Percentage of participants with earlier healing of wound area treated with Oleogel-S10 and non-adhesive wound dressing compared to non-adhesive wound dressing only
Time frame: up to 4 weeks
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Landesklinik für Dermatologie
Salzburg, Austria
Medical University Vienna
Vienna, Austria
University Multiprofile Hospital for Active Treatment-"Dr. Georgi Stranski" EAD
Pleven, Bulgaria
University Multiprofile Hospital for Active Treatment "Saint George"
Plovdiv, Bulgaria
Multiprofile Hospital for Active Treatment- Ruse
Rousse, Bulgaria
University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I.Pirogov"
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment-Varna at MMA-Sofia
Varna, Bulgaria
Universtity Hospital Brno
Brno, Czechia
University Hospital Olomouc
Olomouc, Czechia
...and 14 more locations
Percentage of Participants With Wound Closure at Different Time Points
For separate time points (Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28), the frequencies of wound areas which have reached wound closure were calculated.
Time frame: up to 4 weeks
Percentage of Wound Epithelialization at Different Time Points as Assessed by the Investigator
A study team member assessed the progress of wound healing by treatment regimen and noted the degree of epithelialization (expressed in percent of the original wound size) at wound dressing changes on Day 7, Day 10, Day 14, Day 18, Day 21, and Day 28.
Time frame: up to 4 weeks
Likert Scale Rating of Efficacy
Participants and investigators were asked to grade the efficacy of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only on a 5-point Likert scale (treatment with Oleogel-S10 is much more effective, treatment with Oleogel-S10 is more effective, both treatments have the same efficacy, non-adhesive wound dressing only is more effective, non-adhesive wound dressing only is much more effective).
Time frame: up to 4 weeks
Cosmetic Outcome at 3 and 12 Months After Surgery, Respectively
Blinded photographic evaluation which wound half resembles more closely the surrounding skin with regard to texture, redness, growth of hair, and pigmentation.
Time frame: 3 months and 12 months
Likert Scale Rating of Tolerability
Participants and investigators were asked to evaluate the tolerability of Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only (standard of care) on a 5-point Likert scale (treatment with Oleogel-S10 is much better tolerated, treatment with Oleogel-S10 is better tolerated, both treatments are equally well tolerated, standard of care is better tolerated, standard of care is much better tolerated).
Time frame: up to 4 weeks
Pharmacokinetic (PK) Data (Number of Plasma Samples With Measurable Betulin Concentration)
Systemic presence/concentration of betulin in blood plasma samples. Plasma samples were collected in weekly intervals and at the end of treatment (when wound closure was achieved or at Day 28). Samples were analysed in a central laboratory with a validated LC-MS/MS method with a lower limit of quantification (LLOQ) of 1 ng/mL.
Time frame: up to 4 weeks
Pharmacokinetic (PK) Data (Plasma Betulin Concentration)
Systemic presence/concentration of betulin in blood plasma samples - values for the number of samples with measurable values in samples above the lower limit of quantification (LLOQ) of 1 ng/mL
Time frame: up to 4 weeks
Frequency of Adverse Events
Time frame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Severity of Adverse Events
Adverse Events were graded according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) as being mild (NCI CTCAE Grade 1), moderate (NCI CTCAE Grade 2), severe (NCI CTCAE Grade 3), life-threatening (NCI CTCAE Grade 4) or death (NCI CTCAE Grade 5).
Time frame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).
Adverse Events by Relationship to Study Medication
Adverse events were assessed as being 'unlikely', 'possibly' or 'probably' related to study medication, 'not related' to study medication or the relationship to study medication was rated as 'unknown'.
Time frame: Day 0 (start of treatment) until end of treatment (Day 28 or earlier if full wound closure was achieved earlier).