The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

Association of Dutch Burn Centres

Status

Completed

Conditions

Full Thickness Skin Defects

Treatments

Device: Novomaix dermal substitute in combination with STSG

Study type

Interventional

Funder types

Other

Identifiers

NCT02164760

ESG-09-2012

NL42113.094.12 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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