To investigate the effect of a human-derived donor skin substitute Glyaderm when combined with negative pressure wound therapy in comparison to the gold standard treatment.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is scar elasticity in the grafted burn wound sites at
3, 6 and 12 months post-operatively.
Secondary outcome
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
Background summary
Split thickness skin grafts are the gold standard in the treatment of deep
burns. However, this often results in hypertrophic scarring and contractures,
presumably due to a lack of dermal components. Adding dermal substitution
results in improved scar elasticity and scar quality. Unfavorable wound
conditions in burns may however contribute to substitute degradation, limiting
its effect. Previous studies showed improved substitute efficacy when combining
dermal substitutes with negative pressure wound therapy (NPWT).
Study objective
To investigate the effect of a human-derived donor skin substitute Glyaderm
when combined with negative pressure wound therapy in comparison to the gold
standard treatment.
Study design
An intra-individual, single-blinded, randomised controlled pilot trial.
Intervention
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.
Study burden and risks
Both treatments that participants can be allocated to are standard treatments.
NPWT is also used regularly. There will be no extra burden for study
participants in the frequency of follow-up visits. Study participants will have
to complete a questionnaire regarding scar symptoms and undergo extra
non-invasive scar measurements regarding elasticity and colour. There are no
extra risks when participating in this study compared to regular treatment.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Deep dermal to full thickness burn wounds requiring surgery for wound
healing/closure in adults.
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77058.091.21 |