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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Percentage of healing between VAC system and compresses for all types of leg ulcers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
V.A.C.® Therapy
In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.
Intervention: V.A.C.® (Device)
usual dressing method (compresses)
In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.
Intervention: dressing (Device)
Outcomes
Primary Outcomes
Percentage of healing between VAC system and compresses for all types of leg ulcers
Time Frame: 1 month after the transplant
Number of patients having a wound at least 50% of the grafted area between VAC system and compresses
Secondary Outcomes
- Percentage of healing between VAC system and compresses for all types of leg ulcers(3 months after the transplant)
- Evolution of the pain by Analogic Visual Scale.(day 1 : the day after the transplant)
- Evolution of the pain by Analogic Visual Scale(Month 1)
- Cost of the treatment.(Month 3)
- Quality of life questionnaire score.(Month 3)
- Evolution of the pain by Analogic Visual Scale.(day 0 : just before the transplant)
- Quality of life questionnaire score.(day 0 : just before the transplant)
- Quality of life questionnaire score.(Day 5)
- Quality of life questionnaire score.(Month 1)