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Clinical Trials/NCT01427491
NCT01427491CompletedPhase 3

A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.

ConvaTec Inc.6 sites in 1 country18 target enrollmentStarted: August 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
18
Locations
6
Primary Endpoint
Microbial load reduction
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Microbial load reduction

Time Frame: Days 1 and 14

The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.

Secondary Outcomes

  • clinical evolution of the wound (presence of each of the selected clinical signs)(Days 1, 3, 7, 14)
  • Occurrence of adverse events(Day 1-14)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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