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

Leg Injury Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02963519
• Other study ID #: 2016-A00448-43
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2016
• Last updated: November 14, 2016
• Start date: November 2016
• Est. completion date: January 2018

Study information

• Verified date: November 2016
• Source: Qualissima
• Contact: François Dufay
• Email: francois.dufay[@]dtamedical.com
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: January 2018
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Injuries
• Leg Injury

Intervention

Device:
• VistaCare®

• Dressings

Locations

Country	Name	City	State
France	Hopital Conception	Marseille
France	CHU Nantes	Nantes
France	Hôpital Saint Louis	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Qualissima	DTA Medical

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No