Effectiveness of Dermal Substitution and Negative Pressure Wound Therapy in Burns: a Randomized Controlled Pilot Study
Recruiting
- Conditions
- (deep dermal to full thickness) burn wounds10040795
- Registration Number
- NL-OMON50928
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Inclusion Criteria
Deep dermal to full thickness burn wounds requiring surgery for wound
healing/closure in adults.
Exclusion Criteria
Wounds not suitable for negative pressure wound therapy application; solitary
facial burns; infected wounds; patients suspected to be non-compliant, i.e.. in
case of severe cognitive dysfunction or psychiatric disorders; pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study endpoint is scar elasticity in the grafted burn wound sites at<br /><br>3, 6 and 12 months post-operatively.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate the effect of Glyaderm on graft take<br /><br>To investigate the effect of Glyaderm on wound epithelialisation<br /><br>To investigate the effect of Glyaderm on scar pigmentation and vascularisation.<br /><br>To investigate incidence of burn wound infection by clinical evaluation and<br /><br>taking bacterial swabs at certain time points<br /><br>To investigate incidence of other complications<br /><br>To investigate the effect of Glyaderm on scar quality as judged by an<br /><br>experienced clinician using a validated questionnaire<br /><br>To investigate the effect of Glyaderm on scar quality as judged by the patient<br /><br>using a validated questionnaire</p><br>