Oleogel-S10 in Wound Healing of Split-Thickness Skin Graft Donor Sites (BSG-12) (BSG-12)
Wounds
About this trial
This is an interventional treatment trial for Wounds focused on measuring 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
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.
Sites / Locations
- CHU de Bordeaux
- Hôpital de la Conception
- CHU de Nantes
- KAT General Hospital of Attica
- National University, "Andreas Syggros" Skin & Venereal Diseases Hospital
- Aristotle University General Hospital
- Riga East University Hospital, Microsurgery Center
- Riga East University Hospital, State Burn Center
- Hospital de la Santa Creu i Sant Pau
- Hospital Universitari Vall d'Hebron
- Hospital Universitario de Getafe
- Hopital Universitari i Politecnic La Fe
- Hospital Universitario Rio Ortega
- Hospital Miguel Servet
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Oleogel-S10, non-adhesive wound dressing
Non-adhesive wound dressing only
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.
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.