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

URGO Group

Status

Unknown

Conditions

Venous Leg Ulcer

Treatments

Device: URGO2875

Study type

Interventional

Funder types

Industry

Identifiers

NCT03670329

F-08-07-AWC008

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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