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Completed

NCT Number: NCT02164760

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

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.

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Key information

Conditions

Full Thickness Skin Defects Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie, Berlin, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novomaix dermal substitute in combination with STSG

Device

Novomaix dermal substitute in combination with STSG

Other names: Novomaix

Primary outcomes

  1. Graft take (experimental vs control area)

    Time frame: 5-7 days postoperative

    Subjective assessment of two experienced observers

Secondary outcomes

  1. Epithelialization

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

    Subjective assessment of two experienced observers

  2. Complication rate

    Time frame: Up to 12 months postoperative

    Measurement of re-operations, infection rate by culture swabs

  3. Scar quality

    Time frame: 3 months

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

  4. Scar quality

    Time frame: 6 months

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

  5. Scar quality

    Time frame: 9 months

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

  6. Scar quality

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Collaborators

  • Ernst Reichmann Tissue Biology Research Unit, Zürich
  • Seventh Framework Programme

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jun 17, 2014
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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