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Dermal Substitute and Topical Negative Pressure in Burns

NCT00548314 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2011-03-24

No results posted yet for this study

Summary

The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.

Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

Conditions

  • Burns

Interventions

OTHER

dermal matrix

1mm thickness matrix composed of collagen-elastin hydrolosate

PROCEDURE

Split skin graft

DEVICE

VAC therapy (KCI)

VAC therapy for 3-5 days 125mmHg

Sponsors & Collaborators

  • Association of Dutch Burn Centres

    lead OTHER

Principal Investigators

  • Esther Middelkoop, Professor · Association of Dutch Burn Centres (ADBC)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-05-31
Completion
2011-02-28

Countries

  • Netherlands

Study Locations

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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 NCT00548314 on ClinicalTrials.gov