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OpenTrials
Completed

NCT Number: NCT01427491

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

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.

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Key information

Conditions

Leg Ulcers Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Willows Centre for Health Care, Weaste, Salford, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquacel® Ag

Device

Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.

Mepilex® Border Ag

Device

Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.

Primary outcomes

  1. 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

  1. clinical evolution of the wound (presence of each of the selected clinical signs)

    Time frame: Days 1, 3, 7, 14

    Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour

  2. Occurrence of adverse events

    Time frame: Day 1-14

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2011
Registry last updated
Jul 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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