NCT02164760

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Association of Dutch Burn Centres · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Full Thickness Skin Defects

Interventions

Type	Name	Description
DEVICE	Novomaix dermal substitute in combination with STSG	Novomaix dermal substitute in combination with STSG

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-12-01
• Completion: 2016-06-01
• First posted: 2014-06-17
• Last updated: 2020-02-17

Locations

2 sites across 2 countries: Germany, Netherlands