An interventional study of V.A.C.® and dressing in Leg Ulcer, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-28.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Treatment
To evaluate the VAC (Vacuum Assisted Closure) therapy in transplants of leg ulcers versus usual dressing method. The VAC Therapy system consists of:
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.
302 studies on the registry are indexed under Leg Ulcer; 43 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 245 interventional studies indexed under Leg Ulcer.
Browse Leg Ulcer studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 597 studies on the registry; 127 are open to participants now.
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Exclusion Criteria:
In this arm, investigators will use the V.A.C.® Therapy after a transplants of leg ulcers.
Device: V.A.C.®
In this arm, investigators will use the usual dressing method after a transplants of leg ulcers.
Device: dressing
Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
Patients received usual dressing method (compresses) after a transplants of leg ulcers
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
Time frame: 1 month after the transplant
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
Time frame: 3 months after the transplant
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Time frame: day 0 : just before the transplant
Evolution of the pain by Analogic Visual Scale.
Pain score as measured by visual analog scale between VAC system and compresses
Time frame: day 1 : the day after the transplant
Evolution of the pain by Analogic Visual Scale
Pain score as measured by visual analog scale between VAC system and compresses
Time frame: Month 1
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Time frame: day 0 : just before the transplant
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Time frame: Day 5
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Time frame: Month 1
Quality of life questionnaire score.
Quality of life questionnaire score between VAC system and compresses
Time frame: Month 3
Cost of the treatment.
Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs
Time frame: Month 3
This study is terminated, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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