Oleogel-S10 in Grade 2a Burn Wounds

• Research type

  Research Study

• Full title

  Open, Blindly Evaluated, Prospective, Controlled, Randomized, Multicenter Phase III Clinical Trial to Compare Intra-individually the Efficacy and Tolerance of Oleogel-S10 versus Standard of Care in Accelerating the Healing of Grade 2a Partial-Thickness Burn Wounds

• IRAS ID

  107724

• Contact name

  Peter Dziewulski

• Sponsor organisation

  Birken AG

• Eudract number

  2012-000362-38

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Burn injury is a serious pathology, potentially leading to severe morbidity and significant mortality, but it also has a considerable health-economic impact. Burns occur at an annual incidence of 2,000 people per million in Europe. Burns can be classified according to the depth of injury into first, second, third and fourth degrees. This study aims to recruit patients with Grade 2a partial-thickness burn wounds. Grade 2a partial-thickness burn wounds are able to regenerate the skin lesion on their own and wound closure takes 10-17 days. This study will compare intra-individually (2 wound halves or 2 similar size wound areas within each subject). One half of the wound will be treated with Oleogel-S10 and the other half with octenilin© Wound Gel for a treatment period of approximately 21 days (the treatment can still continue until the Investigator decides to change medication and/or treatment if wound still open at 21 days), with dressing changes at the latest every second day. The efficacy and tolerance of Oleogel-S10 with fatty gauze as wound dressing versus octenilin© Wound Gel with fatty gauze as wound dressing will be compared using photographs evaluated by three blinded experts and via patient and Investigator questionnaires. The study aims to accelerate the healing process which reduces the potential associated morbidities to the patient including pain and infection. Importantly, accelerated healing correlates with reduced scarring.

• REC name

  East of England - Cambridge Central Research Ethics Committee

• REC reference

  12/EE/0319

• Date of REC Opinion

  31 Aug 2012

• REC opinion

  Further Information Favourable Opinion