Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
62
sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
Sterile dressing that consists of viscose tissue coated with mineral vaseline
Research Facility ID ORG-001183
Angoulème, France
Pain Intensity at Removal of the Primary Dressing, Evaluated by the Subject Just After Removal
Pain intensity experienced by subjects associated to removal of each study primary dressings during the care, assessed at of the Cross-over Period on a visual analogue scale (VAS). The VAS was provided as a 100 mm, non-graduated horizontal line, with extremities indicating " no pain " (0) and " extreme pain " (100). The subject responded by drawing a vertical line to assess the pain intensity he/she experienced at the time of removal of the primary wound dressing.
Time frame: at the time of dressing removal on Day 2 (Visit 2) and Day 4 (Visit 3)
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Research Facility ID ORG-000857
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...and 17 more locations