The main objective of this trial is to demonstrate that a local care strategy using URGO 310 3082 dressing is not inferior to a reference therapeutic strategy using a hydrofibre dressing in the management of venous ulcers. This non-inferiority hypothesis will be judged on the planimetric relative regression of the wound surface area after six weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
159
the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days.
Hopital Rothschild
Paris, France
The efficacy of dressings under trial will be judged on the evolution of wound surface area after six weeks of treatment.
The main evaluation criterion is the relative planimetric regression of the wound surface area, calculated according to the following formula, from centralised planimetric measurements: Regression of the area (%) = \[(ST0-STlast)/ST0\] x 100 ST0: Surface area of the lesion measured on the day of inclusion STlast: Surface area of the lesion at the last planimetric evaluation available
Time frame: Week 1, 2, 4 and 6
Comparison between the two devices of percentage of lesions in which the evolution is positive (defined by a relative regression at least 40% of wound surface) after monitoring for 6 weeks.
Time frame: Week 1, 2, 4 and 6
Comparison between the two groups of percentage of debrided lesions (defined by a lesion with more than 70% of its surface covered by granulation tissue of a "red colour" on the colorimetric scale), at the last available evaluation
Time frame: Week 1, 2, 4 and 6
Comparison between the two strategies of percentage of patients in whom at least one problem of pain was detected during care (VAS score at the end of care > 30 mm)
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of wound care associated with manual debridement
Time frame: Week 1, 2, 4 and 6
Comparison between the two groups of the evolution of the patients' quality of life between inclusion and the last available visit. This quality of life will be assessed using the EuroQol-5D™ questionnaire
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of the participants number with Adverse Events
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Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean number of dressing changes per week.
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the easiness application and removal
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the percentage of good or very good conformability
Time frame: Week 1, 2, 4 and 6
Comparison between the 2 groups of the mean value for overall performance score
This score will be between 0 and 36
Time frame: Week 1, 2, 4 and 6