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

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Conditions

Leg Ulcer

Treatments

Device: dressing

Device: V.A.C.®

Study type

Interventional

Funder types

Other

Identifiers

NCT02509533

2010-A00371-38 (Other Identifier)

1008042

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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