A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

Association of Dutch Burn Centres11 enrolled

Overview

In this study the efficacy 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. The investigators expect this treatment 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. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) 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 (for Zurich: ≤ 18 years) * Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm * ≤ 50% TBSA full thickness skin defects at time of intervention * Informed consent by the patient and/or legal representatives. Exclusion Criteria: * Patients with infected wounds * Full thickness skin wounds located in face and/or genitals will not be included * Pregnant or breast feeding females * Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer) * Known allergy against porcine collagen or elastin * Patients that are expected (according to the responsible medical doctor) to be non-compliant 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 (3)

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie

Berlin, Germany

Red Cross Hospital

Beverwijk, North Holland, Netherlands

Children's Hospital Department of Surgery Kinderspital Zurich

Zurich, Switzerland

Outcomes

Primary Outcomes

Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)

Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)

Time frame: 3 months post-operative

Secondary Outcomes

Graft take (Subjective assessment by experienced observer)

Time frame: 5-7 days

Epithelialisation (Subjective assessment by experienced observer)

Subjective assessment by experienced observer

Time frame: 5-7 days and 2-3 weeks post-operative

Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)

Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire

Time frame: 12 months

Scar quality (As determined with subjective scar assessment scale (POSAS)

As determined with subjective scar assessment scale (POSAS)

Time frame: 3 and 12 months

Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)

As measured for scar colour and pigmentation using DSM II ColorMeter

Time frame: 3 and 12 months

Data from ClinicalTrials.gov

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