Prospective Case Series of Acute Complex Wounds Treated With Glyaderm
Recruiting
- Conditions
- 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.
- Registration Number
- NL-OMON20860
- Lead Sponsor
- ot applicable.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study endpoint is graft take in the grafted wound site(s) in a total follow-up of 12 weeks.
- Secondary Outcome Measures
Name Time Method Wound epithelialisation 5-7 days after split skin graft placement.<br>Day of wound closure (>95% epithelialisation).<br>Incidence of complications: hematoma, graft loss, graft shift, post-operative bleeding, regrafting and wound infection.<br>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)<br>Subjective assessment of the scar after 12 weeks.