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

Primary Purpose

Leg Ulcer

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
V.A.C.®
dressing
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer focused on measuring Vacuum Assisted Closure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU de SAINT-ETIENNE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V.A.C.® Therapy

usual dressing method (compresses)

Arm Description

In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.

In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Evolution of the pain by Analogic Visual Scale
Pain score as measured by visual analog scale between VAC system and compresses
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Cost of the treatment.
Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs

Full Information

First Posted
July 21, 2015
Last Updated
July 27, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02509533
Brief Title
Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
difficulties to recruit patients.
Study Start Date
September 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer
Keywords
Vacuum Assisted Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V.A.C.® Therapy
Arm Type
Experimental
Arm Description
In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.
Arm Title
usual dressing method (compresses)
Arm Type
Active Comparator
Arm Description
In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.
Intervention Type
Device
Intervention Name(s)
V.A.C.®
Intervention Description
Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
Intervention Type
Device
Intervention Name(s)
dressing
Intervention Description
Patients received usual dressing method (compresses) after a transplants of leg ulcers
Primary Outcome Measure Information:
Title
Percentage of healing between VAC system and compresses for all types of leg ulcers
Description
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Time Frame
1 month after the transplant
Secondary Outcome Measure Information:
Title
Percentage of healing between VAC system and compresses for all types of leg ulcers
Description
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Time Frame
3 months after the transplant
Title
Evolution of the pain by Analogic Visual Scale.
Description
Pain score as measured by visual analog scale between VAC system and compresses
Time Frame
day 0 : just before the transplant
Title
Evolution of the pain by Analogic Visual Scale.
Description
Pain score as measured by visual analog scale between VAC system and compresses
Time Frame
day 1 : the day after the transplant
Title
Evolution of the pain by Analogic Visual Scale
Description
Pain score as measured by visual analog scale between VAC system and compresses
Time Frame
Month 1
Title
Quality of life questionnaire score.
Description
Quality of life questionnaire score between VAC system and compresses
Time Frame
day 0 : just before the transplant
Title
Quality of life questionnaire score.
Description
Quality of life questionnaire score between VAC system and compresses
Time Frame
Day 5
Title
Quality of life questionnaire score.
Description
Quality of life questionnaire score between VAC system and compresses
Time Frame
Month 1
Title
Quality of life questionnaire score.
Description
Quality of life questionnaire score between VAC system and compresses
Time Frame
Month 3
Title
Cost of the treatment.
Description
Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno LABEILLE, MD
Organizational Affiliation
CHU de SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de SAINT-ETIENNE
City
Saint-etienne
ZIP/Postal Code
42000
Country
France

12. IPD Sharing Statement

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

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