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

Leg Ulcer Clinical Trial

Official title:
Comparison of the Use of VAC (Vacuum Assisted Closure) System in Transplants of Leg Ulcers Versus Usual Dressing Method. A Monocentric, Prospective, Randomized, Parallel Groups Study

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02509533
Study type Interventional
Source Centre Hospitalier Universitaire de Saint Etienne
Contact
Status Terminated
Phase N/A
Start date September 2010
Completion date March 2014
View Details
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