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OpenTrials
Completed

NCT Number: NCT02228122

The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms

The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manchester Diabetes Centre

Manchester, M13 0JE, United Kingdom

About this study

Background: Chronic wounds and wound infections can be costly, resulting in prolonged hospital stays and an increased risk of secondary infection and septicaemia. In the UK the management of chronic venous leg ulcers is estimated to cost £1 billion/year, with surgical site infections requiring approximately 6.5 days additional hospital stay. Chronic wounds typically harbour a wide variety of bacteria; heavy bacterial colonisation and subsequent biofilm formation has been cited as a factor which induces a chronic inflammatory state and delays healing times.

AQUACEL®Ag+ Extra is a soft conformable flat sheet nonwoven fabric dressing, which forms a gel when it becomes wet. Its physical characteristics have the potential to increase the speed of antimicrobial action of silver and its effectiveness against any recalcitrant wound bioburden. Removing these potential barriers to healing may help towards wound progression.

Aim: This is a pilot study to investigate the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms. Wound debridement tissue will be assessed for the presence/absence of in situ biofilms which will be monitored over 4 weeks and compared to the baseline (non-treatment) sample. Additionally, we will evaluate reductions in wound volume over the treatment period.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Provided written informed consent
  • Be over 18 years of age
  • Must have a chronic foot wound greater than 4 weeks in duration
  • Be willing and able to attend the clinic for the required study visits -

Exclusion criteria

  • Subjects with a history of sensitivity to any one of the components of the device being studied
  • Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
  • Subjects who are currently participating in or have been on a clinical study within the last 4 weeks.

Treatment and study plan

Aquacel® Ag+ Extra

Device

Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks.

Primary outcomes

  1. A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.

    Time frame: up to day 28

    Wound debridement tissue derived from standard of care will be retained for analysis up to Day 28. Tissue to be sectioned and analysed for the presence or absence of bacterial biofilms.

Secondary outcomes

  1. Size of the wound and an indicator of healing

    Time frame: up to day 28

    Weekly measurements of wound size

Sponsors and collaborators

Lead sponsor

Dr Angela Oates

Other

Collaborators

  • ConvaTec Inc.

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 28, 2014
Registry last updated
Dec 2, 2015

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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