Leg Ulcer
Conditions
Keywords
Vacuum Assisted Closure
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.
Interventions
DEVICEV.A.C.®
Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
DEVICEdressing
Patients received usual dressing method (compresses) after a transplants of leg ulcers
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of healing between VAC system and compresses for all types of leg ulcers | 1 month after the transplant | Number of patients having a wound at least 50% of the grafted area between VAC system and compresses |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of healing between VAC system and compresses for all types of leg ulcers | 3 months after the transplant | 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. | day 0 : just before the transplant | Pain score as measured by visual analog scale between VAC system and compresses |
| Evolution of the pain by Analogic Visual Scale | Month 1 | Pain score as measured by visual analog scale between VAC system and compresses |
| Quality of life questionnaire score. | day 0 : just before the transplant | Quality of life questionnaire score between VAC system and compresses |
| Cost of the treatment. | Month 3 | Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs |
Countries
France
Outcome results
None listed