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Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

NCT02509533 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-07-28

No results posted yet for this study

Summary

To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:

* A unit delivering a precise under atmospheric pressure, controlled and regulated in the wound site,
* Consumables necessary for the implementation of the dressing,
* Collecting tanks exudates with gel. VAC therapy is a system using negative pressure. It is known to be efficient into care of chronic wounds and ulcerous wounds by increasing the cicatrisation.

This system is systematically used into the dermatology unit of the CHU of Saint-Etienne after transplants of leg ulcers, but no data confirms the interest of this method compared to usual dressing method. This study will provide this data.

Conditions

  • Leg Ulcer

Interventions

DEVICE

V.A.C.®

Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.

DEVICE

dressing

Patients received usual dressing method (compresses) after a transplants of leg ulcers

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Saint Etienne

    lead OTHER

Principal Investigators

  • Bruno LABEILLE, MD · CHU de SAINT-ETIENNE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-10-31
Completion
2014-03-31

Countries

  • France

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 NCT02509533 on ClinicalTrials.gov