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.
Conditions
Interventions
Surgical application of Glyaderm and a split thickness skin graft in acute deep dermal to full thickness skin and soft tissue defects.
Sponsors
Not applicable.
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Active infection 2. Severe cognitive dysfunction or psychiatric disorders in patient history 3. Skin defects due to burns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is graft take in the grafted wound site(s) in a total follow-up of 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactElleke Munk
Radboudumc
Outcome results
None listed