NCT02373566

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

A Phase 2, Intra-patient Randomised Controlled Multicentre International Study to Evaluate the Efficacy of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Association of Dutch Burn Centres · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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. 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.

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: 2015-02-01
• Primary completion: 2016-02-01
• Completion: 2016-09-01
• First posted: 2015-02-27
• Last updated: 2020-02-17

Locations

3 sites across 3 countries: Germany, Netherlands, Switzerland