deep wounds Full thickness skin defects
Conditions
Interventions
The use of a dermal (combined with a STSG) cellular collagen hydrogel-based
skin graft on a full thickness skin defect.
Sponsors
Universität Zürich
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age > 18 years 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 or positive general microbiological swabs taken from the nose for multi-resistant germs - Patients tested positive for HBV, HCV, syphilis or HIV - Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes) - Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variables for safety are the rate of local infection and graft take. The rate of local infection will be evaluated 4-6 days after transplantation of denovoDerm and at 21 ±1 days after transplantation. This will be evaluated with clinical andmicrobial characteristics by an experienced (plastic) surgeon or medical researcher. Graft take will be evaluated 21 ±1 days after transplantation in a standardized fashion by an experienced (plastic) surgeon or medical researcher. Graft take will be depicted as a percentage of transplanted area. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome variable is the number of adverse events. This will be evaluated during clinical admission to the hospital and during outpatient visits. | — |
Countries
Netherlands
Outcome results
None listed