Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers (NCT01427491) | Clinical Trial Compass
CompletedPhase 3
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
United Kingdom18 participantsStarted 2011-08
Plain-language summary
The purpose of this study is to compare the ability of Aquacel® Ag and Mepilex® Border Ag to manage bioburden in leg ulcers over a two week study period.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 18 years or over
* Willing and able to provide written informed consent
* Leg ulcer will be of size ranging between 10 cm2 - 40 cm2 with moderate or heavy exudate
* Leg ulcer will exhibit at least 2 of the 4 following clinical signs: pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
Exclusion Criteria:
* Known skin sensitivity to any component of the products being tested
* Subjects who have had current local or systemic antibiotics and/or topical antimicrobials applied in the week prior to inclusion
* Depth of ulcer classified as superficial (not involving dermis) or deep (exposing muscle and tendon)
* Any other medical condition which, according to the investigator, justifies the subject's exclusion from the study
* Participated in a clinical study within the past 30 days