To investigate the efficacy of the acellular dermal substitute Glyaderm on wound healing in various acute complex skin and soft tissue defects.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
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
Secondary study outcomes are:
- wound epithelialisation 5-7 days after STSG application;
- wound closure in days after STSG application
- complications: hematoma, graft loss/shift, postoperative bleeding,
regrafting, wound infection;
- patient and clinicians assessment of the scar after 12 weeks.
Background summary
Acute complex skin and soft tissue defects of different aetiologies can prove
difficult to heal. When flap assisted closure is not an option, dermal
substitutes can aid in wound closure of these defects. Glyaderm is a low-cost
acellular dermal substitute derived from cadaveric human donors. It is applied
in deep dermal to full thickness burns requiring grafting for healing. Further
research is needed to explore the efficacy on wound healing when applying
Glyaderm in different acute complex skin and soft tissue defects.
Study objective
To investigate the efficacy of the acellular dermal substitute Glyaderm on
wound healing in various acute complex skin and soft tissue defects.
Study design
Prospective case series.
Intervention
Surgical application of Glyaderm and a split thickness skin graft in a one- or
two-staged procedure.
Study burden and risks
There are no extra risks compared to regular treatment, which encompasses
vacuum-assisted therapy and/or the direct application of split thickness skin
grafts or free/local flap surgery. There will be no extra burden for study
participants in the frequency of follow-up visits nor will any invasive
measurements be performed. Accelerated wound closure may be expected in these
wounds treated with Glyaderm.
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Age >=18 years old
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
Exclusion criteria
Active infection
Severe cognitive dysfunction or psychiatric disorders in patient history
Burns
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77377.091.21 |