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

Birken AG

Status and phase: Completed; Phase 3

Conditions: Wounds

Treatments: Drug: Oleogel-S10, non-adhesive wound dressing; Device: Non-adhesive wound dressing only

Study type: Interventional

Funder types: Industry

Identifiers

NCT01657305

2012-000777-23 (EudraCT Number)

BSH-12

Details and patient eligibility

About

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.

Full description

Oleogel-S10 has shown efficacy and was well tolerated in previous clinical trials in participants with skin lesions. Especially the results in a previous study with STSG donor sites suggested that Oleogel-S10 should be efficacious and safe in the treatment of superficial wounds.

The present phase III clinical trial in STSG donor sites was initiated to demonstrate wound healing progress, i.e., the time to healing and the grade of epithelialization of the wound.

In this study, STSG donor sites were separated into 2 wound halves. Randomly assigned, 1 wound half was treated with Oleogel-S10 and non-adhesive wound dressing, the other wound half with non-adhesive wound dressing only (standard of care).

Wound healing progress was documented by photos which were assessed by expert reviewers blind to the treatment of the wound halves.

Enrollment: 107 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 and with a minimum width of 3 cm.
• Patient is able to understand the Informed Consent Form (ICF) provided and is prepared to comply with all study requirements, including the following: Visiting the trial site for wound dressing change and photo documentation every third or fourth day until both wound halves are closed (but no longer than 28 days after surgery).
• Willing to perform all necessary wound dressing changes at the trial site. Also the patient needs to agree to return to site for 3 and 12 months follow-up visits.
• Women of childbearing potential must apply highly effective method of birth control (failure rate less than 1% per year when used consistently and correctly (e.g., implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner)).

Exclusion criteria

• Diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety or efficacy.
• A skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
• A history of clinically significant hypersensitivity to any of the drugs, surgical dressings or excipients to be used in this trial.
• Known multiple allergic disorders.
• Taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
• Pregnant or breast feeding women are not allowed to participate in the study.
• Inappropriate to participate in the study, for any reason, in the opinion of the investigator.
• Mental incapacity or language barriers precluding adequate understanding the Informed consent form or co-operation or willingness to follow study procedures.
• Previous participation in this study.
• Employee at the investigational site, relative or spouse of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

107 participants in 2 patient groups

Oleogel-S10, non-adhesive wound dressing

Experimental group

Description:

A split-thickness skin graft (STSG) donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to Oleogel-S10 treatment and non-adhesive wound dressing (intra-individual comparison). Oleogel-S10 was administered (1 cm or 100 mg per cm2 wound area corresponding to thickness of about 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Treatment:

Drug: Oleogel-S10, non-adhesive wound dressing

Non-adhesive wound dressing only

Other group

Description:

A STSG donor site wound \>15cm2 in size was divided in 2 halves. One half was randomized to treatment with non-adhesive wound dressing only (intra-individual comparison). Non-adhesive wound dressings are standard of care (SOC) in the treatment of STSG donor sites. Wound dressings were changed every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.

Treatment:

Device: Non-adhesive wound dressing only