Conditions: Burns
Keywords: Wound healing Burn wound Superficial partial-thickness burn wound Grade 2a burn wounds Time to wound closure
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 61
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Intra-individual comparison. Oleogel-S10 ointment is administered to one randomly assigned wound half. arm 2: Intraindividual comparison: The other wound half receives disinfectant Octenilin® wound gel.

Interventions: intervention 1: Oleogel-S10 ointment intervention 2: Octenilin® wound gel
Intervention descriptions: intervention 1: Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing intervention 2: Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing

Protocol document: