Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a European, randomised clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).
Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
Hospital Rothschild
Paris, France
RECRUITINGRelative regression of wound surface area
Time frame: week 20
Percentage of debrided wounds
Time frame: at each clinical evaluation up to 20 weeks
Occurrence of adverse events as assessed by the investigator according to a classification MedDRA
Time frame: between inclusion and week 20
Patient's Quality of Life
Time frame: at inclusion visit and at week 20 or at the end of study treatment
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