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ID
Source
Brief title
Health condition
Burns
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scar elasticity at 3, 6 and 12 months post-operatively
Secondary outcome
Graft take, epithelialisation, complications, scar pigmentation/vascularisation, POSAS observer/patient scale
Background summary
Split thickness skin grafts are the gold standard in the treatment of deep burns. 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). The objective of this tstudy is 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 objective
Improved scar quality in burns treated with Glyaderm + STSG + NPWT
Study design
3, 6 and 12 months
Intervention
Glyaderm, split thickness skin graft and negative pressure wound therapy
Inclusion criteria
1. Deep dermal to full thickness burn wounds requiring excision and skin grafting
2. Age ≥18 years old
3. Two anatomically comparable wounds of ≥10 cm2 or one wound surface area of ≥64 cm2
4. Written informed consent
Exclusion criteria
1. Wounds not suitable for NPWT application
2. Solitary facial burns
3. Infected wounds
4. Patients suspected to be non-compliant, i.e. in case of severe cognitive dysfunction or psychiatric disorders
5. Pregnancy
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL9834 |
| Other | METC Oost-Nederland : 2021-7412 |