Application of cultured autologous keratinocytes in combination with a meshed split skin autograft for burn wound healing
Phase 2
Completed
- Conditions
- deep (third degree) burn wounds10014982
- Registration Number
- NL-OMON35395
- Lead Sponsor
- niversitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
-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
Exclusion Criteria
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The % of wound closure after 7 days. Wound closure will be monitored by an<br /><br>experienced surgeon. The exact area will be assessed using computerized<br /><br>planimetric determination. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Scar quality at three and 12 months after operation will be assessed using the<br /><br>POSAS, cutometer to measure scar elasticity, dermaspectometer to assess scar<br /><br>colour and Primos 3D to assess the smoothness of the scar. </p><br>