Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds (NCT01657292) | Clinical Trial Compass
CompletedPhase 3
Oleogel-S10 Versus Standard of Care in Healing of Grade 2a Burn Wounds
Germany, Sweden61 participantsStarted 2012-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sunbur…
What they're measuring
1
Percentage of Patients With Earlier Healing of the Wound Half Treated With Oleogel-S10 Compared to the Wound Half Receiving Standard of Care