Venous Leg Ulcer
Conditions
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.
Interventions
DEVICEURGO2875
Dressing
Sponsors
Laboratoires URGO
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-comparative study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound surface area | 4 weeks | Relative wound surface area reduction (%) at the end of the four weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory clinical signs | 4 weeks | The decrease of the clinical score, based on the presence of the five inflammatory clinical signs, |
| Percentage of wounds with a favourable outcome | 4 weeks | Defined as a relative wound area reduction of at least 40% after the 4-week treatment period |
| Healing | 4 weeks | Percentage of Healing wound |
| Patient quality of life | 4 weeks | Patient quality of life assessed with EuroQoL 5D-5L |
| Time to healing | 4 weeks | Wound Healing time in days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | 4 weeks | Adverse event related to the use of the testing dressing (serious/ non-serious) will be described. |
Contacts
Primary ContactBATOT Ms Geraldine, PhD
Backup ContactTACCA Mr Olivier, PhD
Outcome results
None listed