Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Condition: Burns
MeSH terms: Burns
Intervention: Oleogel-S10 ointment; Octenilin® wound gel
Intervention description: Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing; Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
Intervention MeSH terms: Octenidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Wound healing; Burn wound; Superficial partial-thickness burn wound; Grade 2a burn wounds; Time to wound closure

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at least 18 years old who have provided written informed consent.

          -  Presenting with acute grade 2a burn wounds (as graded by an expert surgeon assisted by
             LDI or a multispectral imaging system) within 48 hours after injury.

          -  Burn wound caused by fire burn, heat burn or scalding.

          -  Burn patients with grade 2a burn wounds between 80 cm2 and less than 25% of their TBSA
             (alternatively, 2 comparable wounds with size more than 40 cm2 each and less than
             12.5% of the TBSA each are allowed).

          -  Patient is able to understand the Informed Consent Form provided and is prepared to
             comply with all study requirements, including the following: Visiting the trial site
             for wound dressing changes at least every second day (if patient is not hospitalized)
             and photo documentation until full wound closure or until the Investigator decides to
             change medication and/or treatment after day 21 after start of treatment

          -  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:

          -  Suffering from chemical burns, or electrical burns or sunburns

          -  Having already received treatment for their burn with silver sulfadiazine (obscures
             photographic wound evaluation).

          -  Positive blood culture after the burn.

          -  Diseases or conditions that could, in the opinion of the Investigator, interfere with
             the assessment of safety, tolerance 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 or surgical
             dressings 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 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