Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-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: 112.0
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 show safety and efficacy of
      Oleogel-S10 in accelerating the wound healing of Split-Thickness Skin Graft (STSG) donor
      sites.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants at least 18 years old who have provided written informed consent

          -  Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2
             and with a minimum width of 3 cm.

          -  Participant was able to understand the Informed Consent Form (ICF) provided and was
             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 were closed (but no longer than 28 days after surgery).

          -  Willing to perform all necessary wound dressing changes at the trial site. Also the
             participant needed to agree to return to site for 3 and 12 months follow-up visits.

          -  Women of childbearing potential who were in the period between menarche and menopause
             needed to apply a 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). Birth control method needed to have been
             applied for at least 1 monthly cycle prior to first administration of study drug, be
             maintained during the study treatment phase and continued for at least 30 days after
             the last administration of study drug. Sexually active, non-vasectomized men needed to
             use a barrier method (condoms) during the treatment phase of this clinical trial.

        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 was chronic or currently active and which the Investigator
             considered would adversely affect the healing of the acute wounds or involved 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 were 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 ICF 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.