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

Not Applicable

Terminated

• Conditions: Leg Ulcer
• Interventions: Device: V.A.C.®; Device: dressing

• Registration Number: NCT02509533
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2013-10
• Study Completion: 2014-03
• Status Verified: 2015-07
• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-07-27
• Last Update Submitted: 2015-07-27
• Study First Posted: 2015-07-28
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V.A.C.® Therapy	V.A.C.®	In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.
usual dressing method (compresses)	dressing	In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.

Primary Outcome Measures

Name	Time	Method
Percentage of healing between VAC system and compresses for all types of leg ulcers	1 month after the transplant	Number of patients having a wound at least 50% of the grafted area between VAC system and compresses

Secondary Outcome Measures

Name	Time	Method
Evolution of the pain by Analogic Visual Scale	Month 1	Pain score as measured by visual analog scale between VAC system and compresses
Percentage of healing between VAC system and compresses for all types of leg ulcers	3 months after the transplant	Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Evolution of the pain by Analogic Visual Scale.	day 1 : the day after the transplant	Pain score as measured by visual analog scale between VAC system and compresses
Cost of the treatment.	Month 3	Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs
Quality of life questionnaire score.	Month 3	Quality of life questionnaire score between VAC system and compresses

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France