Clinical trial NCT02963519: Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of VistaCare® Versus Dressings
Official title: Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Leg Injury
Lead sponsor: Qualissima
Sponsor class: OTHER
Collaborators: name: DTA Medical
First posted: 2016-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary objective:

Demonstrate that in patients with acute leg wounds with skin defect, VistaCare® accelerates the formation of a quality granulation tissue and reduces preparation time to a cover gesture.

Secondary objectives:

* Evaluate the success of hedging gesture
* Assess the quality of the bud by colorimetry
* Assess tolerance
* Collect medical and economic data on the care of patients included
* Evaluate the quality of life of patients
* Assess patient comfort
* Evaluate the ease of use for the caregiver


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Age from 18 to 65 inclusive
* Patient with acute or leg sores (s), traumatic, with skin defect with or without external fixators and without exposure to fine fabrics (functional tendon, artery, vessel, bone, osteosynthesis material ...). These wounds may be burns, deep second degree only.
* Patient having no associated pathology
* Patient has given its written consent, lighting, dated and signed
* Patient affiliated to a social security scheme
* Voluntary Patient and able to comply with the protocol requirements
* Patient whose wound is located below the knee
* Patient whose wound date of less than 2 weeks
* A patient whose wound has a minimum area of 10 cm2
* Patient whose wound does not require surgical debridement after inclusion (if surgical debridement is necessary, it must be performed before inclusion in the study)

Exclusion Criteria:

* Pregnant or breastfeeding women
* Women of childbearing potential not using effective contraception (combined hormonal, IUD) and failing achieving a pregnancy test and getting the result before starting treatment
* Patients do not speak and do not read French
* Patient with one or more risk factors such as smoking more than 5 cigarettes a day, diabetes, autoimmune disease
* Patients with such treatment during or within one month prior to inclusion in the study: corticosteroids, topical corticosteroids at the immunosuppressive wound or radiotherapy
* A patient whose wound is located at a place not compatible with the use of VistaCare®
* Patient with traumatic wound leg with exposure to some tissues (functional tendon, artery, vessel, bone, osteosynthesis material ...)
* Patient with general signs of infection (temperature, lymphangitis, osteitis proven)
* Patient with a bleeding wound
* Patient with a burn to a stage other than deep second degree
* Patients with a wound whose area is less than 10 cm2
* Patient with a plague of nontraumatic leg
* Previous participation in this trial
* Patient in exclusion period from another clinical trial or participated in a clinical trial in the month before inclusion
* Patient whose wound is more than 2 weeks
* Patient whose wound was treated by hyperbaric chamber

Primary outcomes:
measure: Quality of the bud
timeFrame: Change from inclusion day at Day 15 of the quality of the bud
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Conception
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hôpital Saint Louis
Study officials:
affiliation: APHM
name: Dominique Casanova
role: PRINCIPAL_INVESTIGATOR
References: