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

Not Applicable

Completed

• Conditions: Full Thickness Skin Defects
• Interventions: Device: Novomaix dermal substitute in combination with STSG

• Registration Number: NCT02164760
• Lead Sponsor: Association of Dutch Burn Centres

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.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-06-11
• Study First Submitted QC: 2014-06-13
• Study First Posted: 2014-06-17
• Primary Completion: 2015-12
• Study Completion: 2016-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermal substitute with STSG	Novomaix dermal substitute in combination with STSG	Novomaix dermal substitute in combination with STSG

Primary Outcome Measures

Name	Time	Method
Graft take (experimental vs control area)	5-7 days postoperative	Subjective assessment of two experienced observers

Secondary Outcome Measures

Name	Time	Method
Complication rate	Up to 12 months postoperative	Measurement of re-operations, infection rate by culture swabs
Epithelialization	5-7 and 18 ± 2 days days postoperative	Subjective assessment of two experienced observers
Scar quality	12 months	As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale

Trial Locations

Locations (2)

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie; 🇩🇪 Berlin, Germany

Red Cross Hospital; 🇳🇱 Beverwijk, Noord-Holland, Netherlands