Full thickness skin defects scar problems
Conditions
Interventions
In each patient a wound will be covered with Novomaix plus STSG and a
comparable wound will be covered with conventional STSG as control (standard)
treatment.
Sponsors
University of Zurich - Tissue Biology Research Unit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Competent and temporarily incompetent patients age > = 18 years with full thickness skin defects that require skin grafting AND - Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm AND -
Exclusion criteria
Exclusion criteria: When any of the following criteria are met, the potential subject will be excluded from participation in this study: - Patients with infected wounds - Full thickness skin wounds located in face and/or genitals will not be included - Pregnant or breast feeding females - Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer) - Known allergy against porcine collagen or elastin - Patients that are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. (This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders) - Previous enrolment of the patient into the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| How does the scar quality skin elasticity obtained after full thickness wounds compare between wounds treated with Novomaix and STSG to those treated with STSG alone 3 months post surgery? | — |
Secondary
| Measure | Time frame |
|---|---|
| - What is the initial graft take 5-7 days post-operative as determined by visual examination by an observer. - How does the progress of wound healing/ epithelialisation of the wounds compare between treatment with Novomaix plus STSG and STSG alone 5-7 days and 2-3 weeks post-operative? - How does the scar quality obtained after full thickness wounds compare between wounds treated with Novomaix and STSG to that treated with STSG alone as determined by the scar assessment scale (POSAS) and the colour/pigmentation measurement (DSM II Dermaspectrometer) 3 and 12 months post-operative? - How does the scar quality obtained after full thickness wounds compare between wounds treated with Novomaix and STSG to those treated with STSG alone as determined by elasticity measurements (Cutometer®) 12 months post-operative? | — |
Countries
Netherlands
Outcome results
None listed