Management of Infection Risk in Non-comparative Trial (MINT)

NCT ID: NCT03670329

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-31
• Study Completion Date: 2019-11-30

Brief Summary

The URGO2875 dressing is an innovative antimicrobial dressing made of exclusive technologies of TLC-Ag healing matrix and fibres. The dressing has been developed for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

The purpose of this non-comparative clinical trial was to evaluate the performance (efficacy and safety) of the URGO2875 dressing, on the healing process of chronic wounds presenting a high-risk of infection.

Detailed Description

The URGO2875 dressing is indicated for the local treatment of chronic (leg ulcers, pressure ulcers, diabetic foot ulcers) and acute (burns, traumatic wounds, surgical wounds) moderately to highly exudative wounds at risk or with signs of local infection.

Conditions

Venous Leg Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

URGO2875

Dressing

Group Type: EXPERIMENTAL

URGO2875

Intervention Type: DEVICE

Dressing

Interventions

URGO2875

Dressing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Adult patient, aged ≥ 18 years, who signed and dated informed consent form,
• Patients affected by VLU or mixed ulcer of predominantly venous origin (ankle brachial pressure index (ABPI) ≥ 0.7 and ≤ 1.3),
• Patient willing and able to wear an effective venous compression system every day during the study period,
• Patient with at least three of the five inflammatory clinical signs : pain between dressing changes, periwound erythema, local oedema, malodour and presence of heavy exudate.

Exclusion Criteria

• Patients under guardianship or protection of vulnerable adult
• Pregnancy or breastfeeding women,
• Childbearing potential women with no medically-acceptable method of birth control,
• Patients included in another clinical study,
• Patients with known allergy with hydrocolloid (carboxymethylcellulose CMC), silicone or silver,
• Patients with wound covered partially or totally with necrotic tissue,
• Patients who had within the 3 months prior the inclusion, deep vein thrombosis
• Patients with a serious general disease that deemed to interfere with the treatment period and evaluation
• Patients with progressive neoplastic lesions treated by radiotherapy, chemotherapy or hormone therapy
• Patients with non-controlled systemic infection by an suitable antibiotic therapy
• Patients with clinically infected wound
• Patients with wound requiring surgical treatment or for which surgery is scheduled during the study period
• Patients with known cancerous lesions

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Laboratoires URGO

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GERI Ms Chloe, MD

Role: PRINCIPAL_INVESTIGATOR

Lapeyronie Hospital, Montpellier- FRANCE

Central Contacts

BATOT Ms Geraldine, PhD

Role: CONTACT

g.batot@fr.urgo.com

+33 (0)3 80 44 28 46

TACCA Mr Olivier, PhD

Role: CONTACT

o.tacca@fr.urgo.com

+33 (0)3 80 44 74 22

Other Identifiers

F-08-07-AWC008

Identifier Type: -

Identifier Source: org_study_id