Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers

Convatec

Status and phase: Completed; Phase 3

Conditions: Leg Ulcers

Treatments: Device: Aquacel® Ag; Device: Mepilex® Border Ag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01427491

CW-0142-11-U358

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Aquacel® Ag

Active Comparator group

Treatment:

Device: Aquacel® Ag

Mepilex® Border Ag

Active Comparator group

Treatment:

Device: Mepilex® Border Ag