A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Full Thickness Skin Defects
- Sponsor
- Association of Dutch Burn Centres
- Enrollment
- 13
- Locations
- 2
- Primary Endpoint
- Graft take (experimental vs control area)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥18 years
- •with acute burns/trauma wounds that require skin grafting (group 1) OR
- •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
Outcomes
Primary Outcomes
Graft take (experimental vs control area)
Time Frame: 5-7 days postoperative
Subjective assessment of two experienced observers
Secondary Outcomes
- Complication rate(Up to 12 months postoperative)
- Epithelialization(5-7 and 18 ± 2 days days postoperative)
- Scar quality(12 months)