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

Primary Purpose

Leg Injury

Status

Unknown status

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

VistaCare®

Dressings

About this trial

This is an interventional treatment trial for Leg Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hopital Conception
CHU Nantes
Hôpital Saint Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VistaCare®

Dressings

Arm Description

VistaCare® Medical device for treatment into an editable atmosphere

Dressings Adapted to the case

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02963519

First Posted

November 2, 2016

Last Updated

November 14, 2016

Sponsor

Qualissima

Collaborators

DTA Medical

1. Study Identification

Unique Protocol Identification Number

NCT02963519

Brief Title

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

Acronym

VISTACARE01

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2016 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qualissima

Collaborators

DTA Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leg Injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VistaCare®

Arm Type

Experimental

Arm Description

VistaCare® Medical device for treatment into an editable atmosphere

Arm Title

Dressings

Arm Type

Active Comparator

Arm Description

Dressings Adapted to the case

Intervention Type

Device

Intervention Name(s)

VistaCare®

Intervention Type

Device

Intervention Name(s)

Dressings

Primary Outcome Measure Information:

Title

Quality of the bud

Description

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.

Time Frame

Change from inclusion day at Day 15 of the quality of the bud

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

François Dufay

francois.dufay@dtamedical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dominique Casanova

Organizational Affiliation

APHM

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hopital Conception

City

Marseille

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dominique Casanova

Facility Name

CHU Nantes

City

Nantes

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Franck Duteille

Facility Name

Hôpital Saint Louis

City

Paris

Country

France

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maurice Mimoun

12. IPD Sharing Statement

Learn more about this trial

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

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