Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing - Cultured keratinocytes for burn wound treatment
- Conditions
- Even standard treatment, transplantation with a (meshed) split skin autograft, does not result in satisfactory functional and cosmetic appearance of the healed wound. Due to limited available donor sites meshes needs to be enlarged. Bigger enlargements of meshes give more scarring and mesh pattern are still visible in scars, probably because wound closure still needs several weeks. Application of cultured autologous keratinocytes may enhance wound closure.MedDRA version: 9.1Level: LLTClassification code 10006795Term: Burns extensive
- Registration Number
- EUCTR2007-004296-19-NL
- Lead Sponsor
- Association of Dutch Burn Centres
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- competent and temporarily incompetent patients 18 years of age or older with acute burn wounds that require widely meshed skin grafting, which do not need immediate excision - minimal study wound area 100 cm2 - maximal study wound area 300 cm2 - maximal TBSA 50% full thickness wounds - Informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Immunocompromised patients - Infected wounds - Use of high doses of (.20mg/pd) corticosteroids and/or cytostatica - Known penicillin allergy - Conditions where the patient is non compliant as judged by a medical specialist
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method