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

Association of Dutch Burn Centres13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Full Thickness Skin Defects

Interventions

Novomaix dermal substitute in combination with STSGDEVICE

Novomaix dermal substitute in combination with STSG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie

Berlin, Germany

Red Cross Hospital

Beverwijk, North Holland, Netherlands

Outcomes

Primary Outcomes

Graft take (experimental vs control area)

Subjective assessment of two experienced observers

Time frame: 5-7 days postoperative

Secondary Outcomes

Epithelialization

Subjective assessment of two experienced observers

Time frame: 5-7 and 18 ± 2 days days postoperative

Complication rate

Measurement of re-operations, infection rate by culture swabs

Time frame: Up to 12 months postoperative

Scar quality

As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale

Time frame: 3 months

Scar quality

As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale

Time frame: 6 months

Scar quality

As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale

Time frame: 9 months

Scar quality

As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale

Time frame: 12 months

Data from ClinicalTrials.gov

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