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

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

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.

Study Overview

• Status: Terminated
• Conditions: Leg Ulcer
• Intervention / Treatment: Device: V.A.C.®; Device: dressing

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-etienne, France, 42000
    • CHU de Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Bruno LABEILLE, MD, CHU de Saint-Etienne

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 21, 2015
• First Submitted That Met QC Criteria: July 27, 2015
• First Posted (Estimate): July 28, 2015

Study Record Updates

• Last Update Posted (Estimate): July 28, 2015
• Last Update Submitted That Met QC Criteria: July 27, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Vacuum Assisted Closure
• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Skin Ulcer; Ulcer; Leg Ulcer
• Other Study ID Numbers: 1008042; 2010-A00371-38 (Other Identifier: ANSM)