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

PHASE3CompletedINTERVENTIONAL
Enrollment

112

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

September 30, 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 (14)

Unknown

CHU de Bordeaux, Bordeaux

Hôpital de la Conception, Marseille

CHU de Nantes, Nantes

KAT General Hospital of Attica, Athens

"National University, Andreas Syggros Skin & Venereal Diseases Hospital", Athens

Aristotle University General Hospital, Thessaloniki

Riga East University Hospital, Microsurgery Center, Riga

Riga East University Hospital, State Burn Center, Riga

Hospital de la Santa Creu i Sant Pau, Barcelona

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Universitario de Getafe, Madrid

Hopital Universitari i Politecnic La Fe, Valencia

Hospital Universitario Rio Ortega, Valladolid

Hospital Miguel Servet, Zaragoza

All Listed Sponsors
lead

Birken AG

INDUSTRY

NCT01807650 - Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12) | Biotech Hunter | Biotech Hunter