Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSH-12)
Condition: Wounds
MeSH terms: Wounds and Injuries
Intervention: Oleogel-S10, non-adhesive wound dressing; Non-adhesive wound dressing only
Intervention description: 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.; 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 107.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Split-Thickness Skin Graft (STSG) donor site; Split-thickness skin graft; STSG; Wound healing; Skin grafting; Superficial wound; Partial-thickness wound; Time to wound closure

Summary:

      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.
    

Eligibility criteria:

        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.