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 Details — Status: Terminated

Administrative data

• NCT number: NCT02509533
• Other study ID #: 1008042
• Secondary ID: 2010-A00371-38
• Status: Terminated
• Phase: N/A
• First received: July 21, 2015
• Last updated: July 27, 2015
• Start date: September 2010
• Est. completion date: March 2014

Study information

• Verified date: July 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: March 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer

Intervention

Device:
• V.A.C.®
Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
• dressing
Patients received usual dressing method (compresses) after a transplants of leg ulcers

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Evolution of the pain by Analogic Visual Scale	Pain score as measured by visual analog scale between VAC system and compresses	Month 1	No
Secondary	Quality of life questionnaire score.	Quality of life questionnaire score between VAC system and compresses	day 0 : just before the transplant	No
Secondary	Quality of life questionnaire score.	Quality of life questionnaire score between VAC system and compresses	Day 5	No
Secondary	Quality of life questionnaire score.	Quality of life questionnaire score between VAC system and compresses	Month 1	No
Secondary	Quality of life questionnaire score.	Quality of life questionnaire score between VAC system and compresses	Month 3	No
Secondary	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	No