Improved scar quality in burns treated with Glyaderm + STSG + NPWT
ID
Bron
Verkorte titel
Aandoening
Burns
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Scar elasticity at 3, 6 and 12 months post-operatively
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Improved scar quality in burns treated with Glyaderm + STSG + NPWT
Onderzoeksopzet
3, 6 and 12 months
Onderzoeksproduct en/of interventie
Glyaderm, split thickness skin graft and negative pressure wound therapy
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9834 |
| Ander register | METC Oost-Nederland : 2021-7412 |