Full-thickness burns
Conditions
Interventions
Intervention: Application of Glyaderm in combination with an autologous split thickness skin graft on debrided deep dermal or full thickness burn wounds.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
No minimum to 15 Years
Inclusion criteria
Inclusion criteria: Full-thickness burnPediatric (< 16 years)Informed consent by parents (<12 years) or parents and patient (12-15 years old)
Exclusion criteria
Exclusion criteria: No informed consent Burn wound < 30 cm2 Clinically infected wounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: The main study parameter is the scar quality measured with the Patient and Observer Scar Assessment Scale (POSAS) observer scale at 3, 6 and 12 months post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To describe: - Graft take and wound epithelialization at 5-7 days postoperatively - Time to complete wound healing (>95% epithelialization) in days - Time to complete donor site healing in days - Wound/scar surface area at day of surgery and 3, 6 and 12 months post-operatively* - Scar quality using the POSAS patient scale, filled out by the parent at 3, 6 and 12 months post-operatively* - Quality of life using the TAPQOL (6 months to 24 months) or PedsQL (2-15 years) at 3, 6 and 12 months post-operatively. - Rate of scar hypertrophy during follow-up* - Rate of scar contractures during follow-up* - Range of motion (for affected joints) at 3, 6 and 12 months post-operatively* *if parents/patients are willing to extend their participation to 24, 36, 48 and 60 months, these variables will continue to be assessed. | — |
Countries
Netherlands
Contacts
Public ContactM.S. Warenburg
Radboud Universitair Medisch Centrum
Outcome results
None listed