MedTrace Logo

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

NCT02164760 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-02-17

No results posted yet for this study

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.

Conditions

  • Full Thickness Skin Defects

Interventions

DEVICE

Novomaix dermal substitute in combination with STSG

Novomaix dermal substitute in combination with STSG

Sponsors & Collaborators

  • Ernst Reichmann Tissue Biology Research Unit, Zürich

    collaborator OTHER

  • Seventh Framework Programme

    collaborator OTHER

  • Association of Dutch Burn Centres

    lead OTHER

Principal Investigators

  • Esther Middelkoop, Prof. dr. · Red Cross Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2015-12-31
Completion
2016-06-30

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02164760 on ClinicalTrials.gov