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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Leg Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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V.A.C.® Therapy

In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.

Group Type EXPERIMENTAL

V.A.C.®

Intervention Type DEVICE

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

usual dressing method (compresses)

In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.

Group Type ACTIVE_COMPARATOR

dressing

Intervention Type DEVICE

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

Interventions

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V.A.C.®

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

Intervention Type DEVICE

dressing

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient hospitalized into the dermatology unit
* patient with an evolutive leg ulcer since more than 1 month
* signed informed consent

Exclusion Criteria

* known allergy to one of dressings used in this study
* patient with a non-treated osteomyelitis
* patient with tumoral tissues into the wound
* patient with raw organ or raw blood vessels
* patient with an anticoagulation treatment with a potentially hemorrhagic curative dose
* patient having hemostasis problems that can lead to hemorrhagic exudates

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No