Wound Heal
Conditions
Brief summary
The prevalence of chronic wounds is around 2 million people in France per year. A chronic wound is a wound that has been evolving for more than 6 weeks. The main causes are: venous causes, arterial causes and microcirculatory causes. In some aetiologies (particularly arterial causes), there is no radical therapeutic solution (no possibility of revascularisation) and the wounds are often difficult to treat and may even eventually lead to amputation. The recommendations for treating wounds are (in addition to carrying out an etiological treatment when possible) to carry out mechanical detersion and to maintain a moist wound environment. In addition to various medical devices such as dressings, adjuvant treatments that are not specific to the etiology of the wound, such as electrotherapy, negative pressure therapy or other devices such as the VistaCare®, are indicated in France.
Detailed description
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.
Interventions
DEVICEvista care
Prospective, open-label, multi-centre study evaluating the performance of the VistaCare® wound healing device in routine practice.
Sponsors
University Hospital, Grenoble
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* -Patient able and willing to comply with the requirements of the including hospitalization for up to 15 days. * Patient whose wound to be studied is located in a location compatible with the use of VistaCare®, namely the leg including the knee but excluding the upper thigh * Agreement of the study no-objection form * Age greater than or equal to 18 years * Patient affiliated to a social security scheme
Exclusion criteria
* -Patient with general signs of infection at the time of inclusion (fever, lymphangitis, pus ...). Patient with active smoking Subject under guardianship or deprived of liberty Failure to obtain patient consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of the healing performance of the VistaCare® device in routine practice in patients with chronic arterial leg wounds. | 2 years |
Countries
France
Contacts
Primary Contactsophie blaise, MD PhD
Backup Contactfatima bouchafa, CRA
Outcome results
None listed