Clinical trial NCT02509533: 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
Overall status: TERMINATED
Phase: NA
Conditions: Leg Ulcer
Keywords: Vacuum Assisted Closure
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of healing between VAC system and compresses for all types of leg ulcers
timeFrame: 1 month after the transplant
Secondary outcomes:
measure: Percentage of healing between VAC system and compresses for all types of leg ulcers
timeFrame: 3 months after the transplant
measure: Evolution of the pain by Analogic Visual Scale.
timeFrame: day 0 : just before the transplant
measure: Evolution of the pain by Analogic Visual Scale.
timeFrame: day 1 : the day after the transplant
measure: Evolution of the pain by Analogic Visual Scale
timeFrame: Month 1
measure: Quality of life questionnaire score.
timeFrame: day 0 : just before the transplant
measure: Quality of life questionnaire score.
timeFrame: Day 5
measure: Quality of life questionnaire score.
timeFrame: Month 1
measure: Quality of life questionnaire score.
timeFrame: Month 3
measure: Cost of the treatment.
timeFrame: Month 3
Other outcomes:
Locations:
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Bruno LABEILLE, MD
role: PRINCIPAL_INVESTIGATOR
References: