Clinical Trial: Comparison of the Use of VAC System in Transplants of Leg Ulcers Versus Usual Dressing Method

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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 G

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.


Detailed Summary:
Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Percentage of healing between VAC system and compresses for all types of leg ulcers [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: day 1 : the day after the transplant ]
    Pain score as measured by visual analog scale between VAC system and compresses
  • Evolution of the pain by Analogic Visual Scale [ Time Frame: Month 1 ]
    Pain score as measured by visual analog scale between VAC system and compresses
  • Quality of life questionnaire score. [ Time Frame: day 0 : just before the transplant ]
    Quality of life questionnaire score between VAC system and compresses
  • Quality of life questionnaire score. [ Time Frame: Day 5 ]
    Quality of life questionnaire score between VAC system and compresses
  • Quality of life questionnaire score. [ Time Frame: Month 1 ]
    Quality of life questionnaire score between VAC system and compresses
  • Quality of life questionnaire score. [ Time Frame: Month 3 ]
    Quality of life questionnaire score between VAC system and compresses
  • Cost of the treatment. [ Time Frame: Month 3 ]
    Cost of the treatment, between VAC system and compresses This coast includes costs of consumables, hospitalisation days and nursing costs


Original Secondary Outcome: Same as current

Information By: Centre Hospitalier Universitaire de Saint Etienne

Dates:
Date Received: July 21, 2015
Date Started: September 2010
Date Completion:
Last Updated: July 27, 2015
Last Verified: July 2015