(deep dermal to full thickness) burn wounds
Conditions
Interventions
Application of Glyaderm, split thickness skin graft and NPWT versus split
thickness skin graft and NPWT in two separate wounds or a split-scar model
after randomisation.
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Deep dermal to full thickness burn wounds requiring surgery for wound healing/closure in adults.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is scar elasticity in the grafted burn wound sites at 3, 6 and 12 months post-operatively. | — |
Secondary
| Measure | Time frame |
|---|---|
| To investigate the effect of Glyaderm on graft take To investigate the effect of Glyaderm on wound epithelialisation To investigate the effect of Glyaderm on scar pigmentation and vascularisation. To investigate incidence of burn wound infection by clinical evaluation and taking bacterial swabs at certain time points To investigate incidence of other complications To investigate the effect of Glyaderm on scar quality as judged by an experienced clinician using a validated questionnaire To investigate the effect of Glyaderm on scar quality as judged by the patient using a validated questionnaire | — |
Countries
Netherlands
Outcome results
None listed