Clinical trial NCT03670329: Management of Infection Risk in Non-comparative Trial (MINT)
Official title: Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Venous Leg Ulcer
Lead sponsor: Laboratoires URGO
Sponsor class: INDUSTRY
First posted: 2018-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-comparative study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Wound surface area
timeFrame: 4 weeks
Secondary outcomes:
measure: Inflammatory clinical signs
timeFrame: 4 weeks
measure: Percentage of wounds with a favourable outcome
timeFrame: 4 weeks
measure: Time to healing
timeFrame: 4 weeks
measure: Healing
timeFrame: 4 weeks
measure: Patient quality of life
timeFrame: 4 weeks
Other outcomes:
measure: Adverse event
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: Lapeyronie Hospital, Montpellier- FRANCE
name: GERI Ms Chloe, MD
role: PRINCIPAL_INVESTIGATOR
References: