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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02228122
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : December 2, 2015
ConvaTec Inc.
Information provided by (Responsible Party):
Dr Angela Oates, University of Manchester

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

Condition or disease Intervention/treatment Phase
Diabetes Chronic Foot Wounds Device: Aquacel® Ag+ Extra Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Aquacel® Ag+ Extra Device: Aquacel® Ag+ Extra
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 Outcome Measures :
  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 Outcome Measures :
  1. Size of the wound and an indicator of healing [ Time Frame: up to day 28 ]
    Weekly measurements of wound size

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02228122

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United Kingdom
Manchester Diabetes Centre
Manchester, United Kingdom, M13 0JE
Sponsors and Collaborators
Dr Angela Oates
ConvaTec Inc.
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Principal Investigator: Andrew J McBain, BSc, PhD University of Manchester
Principal Investigator: Angela Oates, BSc, MSc, PhD, FIBMS University of Manchester

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Responsible Party: Dr Angela Oates, Dr, University of Manchester Identifier: NCT02228122     History of Changes
Other Study ID Numbers: UoM Study REF: 14118
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Dr Angela Oates, University of Manchester:
Chronic wounds
Additional relevant MeSH terms:
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Wounds and Injuries
Carboxymethylcellulose Sodium
Gastrointestinal Agents