Acute complex skin defects will heal using a dermal substitute (Glyaderm).
ID
Bron
Verkorte titel
Aandoening
Acute deep dermal to full thickness skin and soft tissue defect(s) that will either not heal or take weeks to heal without grafting or (free) flap surgery.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study endpoint is graft take in the grafted wound site(s) in a total follow-up of 12 weeks.
Achtergrond van het onderzoek
Acute complex skin and soft tissue defects of different aetiologies can prove difficult to heal. Dermal substitutes can aid in wound closure of these defects. Glyaderm is a low-cost acellular dermal substitute derived from human cadaveric donors. It is often applied in deep dermal to full thickness burns requiring grafting for healing. Our aim is to investigate wound healing when applying Glyaderm in different acute complex skin and soft tissue defects.
Doel van het onderzoek
Acute complex skin defects will heal using a dermal substitute (Glyaderm).
Onderzoeksopzet
Day -7 to -1: eligibility assessment, inclusion
Day 0: surgery
Day 5-7: graft take rate and wound epithelialisation rate assessment
Day x: >95% epithelialisation assessment
Week 12: subjective scar assessment
Onderzoeksproduct en/of interventie
Surgical application of Glyaderm and a split thickness skin graft in acute deep dermal to full thickness skin and soft tissue defects.
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Acute deep dermal to full thickness skin and soft tissue defect(s) that will either not heal or take weeks to heal without grafting or (free) flap surgery*.
2. Age ≥18 years old
3. Written informed consent
*These include, but are not limited to, donor sites of (free) flap harvest, defects after oncological resection, necrotising fasciitis and degloving injury.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Active infection
2. Severe cognitive dysfunction or psychiatric disorders in patient history
3. Skin defects due to burns.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9652 |
| Ander register | METC Oost-Nederland : 2021-8206 |