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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy and Acceptability of URGO2875 Dressing in the Treatment of Leg Ulcers With Inflammatory Signs

Conditions
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Venous Leg Ulcer

Intervention / Treatment
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* Device: URGO2875


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Non-comparative study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URGO2875<br>Dressing | Device: URGO2875<br>* Dressing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound surface area | Relative wound surface area reduction (%) at the end of the four weeks of treatment | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory clinical signs | The decrease of the clinical score, based on the presence of the five inflammatory clinical signs, | 4 weeks | 
| Percentage of wounds with a favourable outcome | Defined as a relative wound area reduction of at least 40% after the 4-week treatment period | 4 weeks | 
| Time to healing | Wound Healing time in days | 4 weeks | 
| Healing | Percentage of Healing wound | 4 weeks | 
| Patient quality of life | Patient quality of life assessed with EuroQoL 5D-5L | 4 weeks |