CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 107 enrolled
Drug / intervention
Oleogel-S10, non-adhesive wound dressing +1 moredrug
Likely dose
Oleogel-S10, non-adhesive wound dressing 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01657305
NCT01657305Phase 3Completed
CompareCT.gov

Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 Versus Standard of Care in Accelerating the Wound Healing of Split-Thickness Skin Graft Donor Sites

Birken AG·interventional·Posted Aug 6, 2012·Updated Jan 23, 2018

In Brief

A Phase 3 clinical trial evaluating Oleogel-S10, non-adhesive wound dressing and Non-adhesive wound dressing only for Wounds. Completed, enrolled 107 participants across 24 sites in 6 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWounds
CountriesAustria, Bulgaria, Czechia, Finland, Germany, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.9 years ago

Interventions

Oleogel-S10, non-adhesive wound dressingdrug

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.

Non-adhesive wound dressing onlydevice

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.