Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of VistaCare® Versus Dressings (VISTACARE01)

Evaluation of Improved Preparation Time to a Coverage in Patients With Acute Wounds by Use of the Medical Device VistaCare® Versus Dressings

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

Study Overview

• Status: Unknown
• Conditions: Leg Injury
• Intervention / Treatment: Device: VistaCare®; Device: Dressings

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France
    • Hopital Conception
  • Nantes, France
    • CHU Nantes
  • Paris, France
    • Hopital saint Louis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VistaCare®; VistaCare® Medical device for treatment into an editable atmosphere	Device: VistaCare®
ACTIVE_COMPARATOR: Dressings; Dressings Adapted to the case	Device: Dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of the bud	Comparison, after the inclusion in the study, between VistaCare® and dressings on preparation time to a cover gesture by daily visual assessment of the quality of the bud.	Change from inclusion day at Day 15 of the quality of the bud

Collaborators and Investigators

• Sponsor: Qualissima
• Collaborators: DTA Medical
• Investigators: Principal Investigator: Dominique Casanova, APHM

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2017
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: November 2, 2016
• First Submitted That Met QC Criteria: November 14, 2016
• First Posted (ESTIMATE): November 15, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): November 15, 2016
• Last Update Submitted That Met QC Criteria: November 14, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries
• Other Study ID Numbers: 2016-A00448-43