burn wounds full thickness skin defects
Conditions
Interventions
All included patients will undergo full thickness removal of the burned skin
or adequate debridement of all necrotic tissue. The wounds of the patients will
be covered with glycerol preserved allogr
Sponsors
Euro Tissue Bank
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • All clearly full thickness burns or skin defects (TBSA Full Thickness Burn
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scar elasticity 12 months post wound healing | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. percentage of Glyaderm® take before application of autografts, 2. healing time and percentage of autograft survival 3. bacterial load 4. scar quality, objective and subjective assessments 4. cost*effectiveness and health related quality of life study (i.e. cost utility analysis). | — |
Countries
Netherlands
Outcome results
None listed