Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)

PHASE3CompletedINTERVENTIONAL
Enrollment

107

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

August 31, 2013

Study Completion Date

September 30, 2014

Conditions
Wounds
Interventions
DRUG

Oleogel-S10, non-adhesive wound dressing

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.

DEVICE

Non-adhesive wound dressing only

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.

Trial Locations (24)

Unknown

Medical University of Graz, Graz

Landesklinik für Dermatologie, Salzburg

Medical University Vienna, Vienna

"University Multiprofile Hospital for Active Treatment-Dr. Georgi Stranski EAD", Pleven

"University Multiprofile Hospital for Active Treatment Saint George", Plovdiv

Multiprofile Hospital for Active Treatment- Ruse, Rousse

"University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I.Pirogov", Sofia

University Multiprofile Hospital for Active Treatment-Varna at MMA-Sofia, Varna

Universtity Hospital Brno, Brno

University Hospital Olomouc, Olomouc

Päijät-Hämeen keskussairaala, Lahti

Satakunnan keskussairaala, Pori

Trauma Hospital, Berlin

University Hospital, Düsseldorf

Essen University Hospital, Essen

University Hospital, Frankfurt

University Medical Center, Freiburg im Breisgau

University Medicine Greifswald, Greifswald

HELIOS Clinic, Krefeld

University Medical Center, Mainz

Klinikum rechts der Isar, München

Klinikum Offenbach am Main, Offenbach

Univesity Hospital Gdansk, Gdansk

Samodzelny Publiczny Szpital Kliniczny Nr. 1, Lublin

All Listed Sponsors
lead

Birken AG

INDUSTRY

NCT01657305 - Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12) | Biotech Hunter | Biotech Hunter