DiabetesNCT02228122
The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms
A study testing Aquacel® Ag+ Extra in people with Diabetes and Chronic Foot Wounds, run by Dr Angela Oates at 1 site in United Kingdom.
Trial summary
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Chronic Foot Wounds
- What is being tested?
- Aquacel® Ag+ Extra
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms
Read the 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.
- Conditions
- Diabetes, Chronic Foot Wounds
- Being tested
- Aquacel® Ag+ Extra
- Keywords
- Chronic wounds, Biofilms, Bacteria
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel® Ag+ ExtraDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aquacel® Ag+ Extra | Experimental | Not described Receives: Device: Aquacel® Ag+ Extra |
What is being measured
The primary outcome is the main question the study is designed to answer.
A measure of the presence/absence of biofilms in over five weeks when exposed to Aquacel Ag+ Extra dressing.
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.
Measured: up to day 28
Secondary outcomes (1)
Size of the wound and an indicator of healing
Weekly measurements of wound size
Measured: up to day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Angela Oates
- Sponsor type
- University, hospital or other
- Collaborators
- ConvaTec Inc.
- Responsible party
- Sponsor-investigator, Dr Angela Oates, University of Manchester
- Investigators
- Andrew J McBain, BSc, PhD, Principal investigator, University of ManchesterAngela Oates, BSc, MSc, PhD, FIBMS, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228122
- Sponsor's protocol ID
- UoM Study REF: 14118
- Status last verified
- Dec 2015
- First submitted
- 26 Aug 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aquacel® Ag+ Extra Dressing on Wound Biofilms
- ClinicalTrials.gov ID
- NCT02228122
- Acronym / sponsor ID
- UoM Study REF: 14118
- Conditions
- Diabetes, Chronic Foot Wounds
- Keywords
- Chronic wounds, Biofilms, Bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Dr Angela OatesUniversity, hospital or other
- Collaborators
- ConvaTec Inc.
- Study start
- Oct 2014
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the research is to assess the effects of Aquacel Ag+ Extra dressing on chronic wound bacterial biofilms
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aquacel® Ag+ Extra | Experimental | Device: Aquacel® Ag+ Extra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquacel® Ag+ ExtraAquacel® 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. | Device | Aquacel® Ag+ Extra |
Primary outcome
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.
1 secondary outcome
Size of the wound and an indicator of healing
Time frame: up to day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew J McBain, BSc, PhD principal investigator
University of Manchester
Angela Oates, BSc, MSc, PhD, FIBMS principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquacel® Ag+ Extra in people with Diabetes and Chronic Foot Wounds, run by Dr Angela Oates at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.