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

NCT ID: NCT02228122

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Chronic Foot Wounds

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aquacel® Ag+ Extra

Group Type EXPERIMENTAL

Aquacel® Ag+ Extra

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ConvaTec Inc.

INDUSTRY

Sponsor Role collaborator

Dr Angela Oates

OTHER

Sponsor Role lead

Responsible Party

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Dr Angela Oates

Dr

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Andrew J McBain, BSc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Angela Oates, BSc, MSc, PhD, FIBMS

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Manchester Diabetes Centre

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UoM Study REF: 14118

Identifier Type: -

Identifier Source: org_study_id