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

Study Overview
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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.

Official Title
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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

Conditions
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Leg Ulcer

Intervention / Treatment
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* Device: V.A.C.®
* Device: dressing


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V.A.C.® Therapy<br>In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers. | Device: V.A.C.®<br>* Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.<br>|
| Active Comparator: usual dressing method (compresses)<br>In this arm, investigators will use the usual dressing method after a transplants of leg ulcers. | Device: dressing<br>* Patients received usual dressing method (compresses) after a transplants of leg ulcers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of healing between VAC system and compresses for all types of leg ulcers | Number of patients having a wound at least 50% of the grafted area between VAC system and compresses | 1 month after the transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of healing between VAC system and compresses for all types of leg ulcers | Number of patients having a wound at least 50% of the grafted area between VAC system and compresses | 3 months after the transplant | 
| Evolution of the pain by Analogic Visual Scale. | Pain score as measured by visual analog scale between VAC system and compresses | day 0 : just before the transplant | 
| Evolution of the pain by Analogic Visual Scale. | Pain score as measured by visual analog scale between VAC system and compresses | day 1 : the day after the transplant | 
| Evolution of the pain by Analogic Visual Scale | Pain score as measured by visual analog scale between VAC system and compresses | Month 1 | 
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | day 0 : just before the transplant | 
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Day 5 | 
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Month 1 | 
| Quality of life questionnaire score. | Quality of life questionnaire score between VAC system and compresses | Month 3 | 
| Cost of the treatment. | Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs | Month 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vacuum Assisted Closure