NCT01657292

Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds

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 Healing of Grade 2a Partial-Thickness Burn Wounds

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Birken AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main goal of this phase III clinical trial is to show safety and efficacy of Oleogel-S10 in the acceleration of wound healing of grade 2a burn wounds.

Detailed description

Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in patients with skin lesions. Especially the results in the split-thickness skin graft donor site, which is regarded as an excellent model for any kind of superficial wounds in human skin, suggest that Oleogel-S10 should be efficacious and safe in treatment of grade 2a burns. The present Phase III clinical trial in grade 2a burns is initiated in order to measure the wound healing progress applying objective methods, i.e., the time to healing and the grade of epithelialization of the wound. In this study, grade 2a burn wounds are separated into two halves: Following wound cleaning and disinfection, wounds are separated into two wound halves. Randomly assigned, one wound half receives Oleogel-S10 ointment, the other wound half standard of care treatment. Wound healing progress is documented by photos which are assessed by expert reviewers blinded to the treatment of the wound halves.

Conditions

• Burns

Interventions

Type	Name	Description
DRUG	Oleogel-S10 ointment	Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
DEVICE	Octenilin® wound gel	Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2012-08-06
• Last updated: 2015-09-28
• Results posted: 2015-09-28

Locations

9 sites across 4 countries: Germany, Sweden, Switzerland, United Kingdom