Clinical Application of a Dermal Substitute based on glycerol preserved Allograft: GLYADERM® A multicentre, prospective, controlled, randomized, comparative trial of Glyaderm® and split thickness skin graft versus split thickness skin graft alone in full thickness skin defects

Completed

Conditions: burn wounds
full thickness skin defects
10022114
10040795

Registration Number: NL-OMON36554

Lead Sponsor: Euro Tissue Bank

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

• All clearly full thickness burns or skin defects (TBSA Full Thickness Burn < 30%) as clinically evaluated by two plastic surgeons and/or specialist burn surgeons
• Possibility to follow the complete treatment schedule until final graft take and subsequently wound healing and finally participation in the follow-up schedule
• Informed consent has been obtained

Exclusion Criteria

•All partial thickness burns that can heal by conservative treatment
•Patients younger than 18 years of age
•TBSA > 30 %
•Study wound smaller than 100 cm² or greater than 800cm2.
•No follow-up till wound closure or withdrawal before start of follow-up
•Patient has any condition(s) that seriously compromises the patient*s ability to complete this study
•Patient has participated in another study utilizing an investigational drug within the previous 30 days
•Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this study

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Scar elasticity 12 months post wound healing </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. percentage of Glyaderm® take before application of autografts,<br /><br>2. healing time and percentage of autograft survival<br /><br>3. bacterial load<br /><br>4. scar quality, objective and subjective assessments<br /><br>4. cost*effectiveness and health related quality of life study (i.e. cost<br /><br>utility analysis).</p><br>