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ID
Source
Brief title
Health condition
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.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is graft take in the grafted wound site(s) in a total follow-up of 12 weeks.
Secondary outcome
Wound epithelialisation 5-7 days after split skin graft placement.
Day of wound closure (>95% epithelialisation).
Incidence of complications: hematoma, graft loss, graft shift, post-operative bleeding, regrafting and wound infection.
Surgical and patient characteristics (timing (time in days between trauma and first reconstructive surgery); number of surgical debridements before reconstructive surgery, surgery duration, total body surface area (%) covered, length of hospital stay)
Subjective assessment of the scar after 12 weeks.
Background summary
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.
Study objective
Acute complex skin defects will heal using a dermal substitute (Glyaderm).
Study design
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
Intervention
Surgical application of Glyaderm and a split thickness skin graft in acute deep dermal to full thickness skin and soft tissue defects.
Inclusion criteria
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.
Exclusion criteria
1. Active infection
2. Severe cognitive dysfunction or psychiatric disorders in patient history
3. Skin defects due to burns.
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
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9652 |
| Other | METC Oost-Nederland : 2021-8206 |