Dermal Substitution in Paediatric Burns: A Prospective Case Series

Recruiting

Conditions: burn injuries
burns
10040795

Registration Number: NL-OMON51349

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

1. Age <=15 years old
2. Burn wounds requiring skin grafting
3. Written informed consent provided by
a. The participant*s parent(s)/guardian (<12 years of age)
b. The participant*s parent(s)/guardian and the participant itself (12-15 years
old)

Exclusion Criteria

1. Burn wound of <=30 cm2
2. Infected burn wounds: clinical symptoms in combination with positive wound
swabs
3. Patients/parents with insufficient knowledge of the Dutch or English
language, since they would not be able to complete the POSAS questionnaire.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the scar quality measured with the POSAS observer<br /><br>scale at 3, 6 and 12 months post-operatively. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Graft take and wound epithelialization at 5-7 days postoperatively<br /><br>- Time to complete wound healing (>95% epithelialization) in days<br /><br>- Time to complete donor site healing in days<br /><br>- Wound/scar surface area at day of surgery and 3, 6 and 12 months<br /><br>post-operatively<br /><br>- Scar quality using the POSAS patient scale, filled out by the parent at 3, 6<br /><br>and 12 months post-operatively<br /><br>- Rate of scar hypertrophy during follow-up<br /><br>- Rate of scar contractures during follow-up<br /><br>- Range of motion (for affected joints) at 3, 6 and 12 months post-operatively<br /><br><br /><br>if parents/patients are willing to extend their participation to 24, 36, 48<br /><br>and 60 months, these variables will continue to be assessed.</p><br>