Full Thickness Skin Defects
Conditions
Keywords
burns, dermal substitute, scar quality, reconstruction, wound healing, wound closure
Brief summary
In this study the safety and feasibility of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. We expect this treatment to be safe, and to provide better outcome regarding scar quality.
Detailed description
Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.
Interventions
Novomaix dermal substitute in combination with STSG
Sponsors
Ernst Reichmann Tissue Biology Research Unit, Zürich
Seventh Framework Programme
Association of Dutch Burn Centres
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years 1. with acute burns/trauma wounds that require skin grafting (group 1) OR 2. with scar problems requiring surgical treatment (group 2) * Full thickness skin defects of 50 cm2 or more, but \<50% TBSA * Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted * Informed consent by the patient
Exclusion criteria
* Patients with infected wounds * Pregnant or breast feeding females * Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer) * Known allergy against porcine collagen or elastin * Patients who are expected (according to the responsible medical doctor) to be noncompliant 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 | Description |
|---|---|---|
| Graft take (experimental vs control area) | 5-7 days postoperative | Subjective assessment of two experienced observers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epithelialization | 5-7 and 18 ± 2 days days postoperative | Subjective assessment of two experienced observers |
| Complication rate | Up to 12 months postoperative | Measurement of re-operations, infection rate by culture swabs |
| Scar quality | 3 months | As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale |
Countries
Germany, Netherlands
Outcome results
None listed