Leg UlcersPhase 3NCT01427491
Compare Aquacel® Ag Versus Mepilex® Border Ag to Manage Bioburden in Leg Ulcers
A Phase 3 study testing Aquacel® Ag and Mepilex® Border Ag in people with Leg Ulcers, run by ConvaTec Inc. at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers
- What is being tested?
- Aquacel® Ag and Mepilex® Border Ag
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2011to Jan 2012
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Wound Healing Research Unit, Cardiff University
Cardiff, Wales, CF14 4XN
Arrowe Park Hospital
Upton, Wirral, CH49 5PE
The Willows Centre for Health Care
Weaste, Salford, M5 2JR
About this study
Official title: A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. 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.
- Conditions
- Leg Ulcers
- Being tested
- Aquacel® Ag, Mepilex® Border Ag
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquacel® AgDevice
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 AgDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aquacel® Ag | Active comparator | Not described Receives: Device: Aquacel® Ag |
| Mepilex® Border Ag | Active comparator | Not described Receives: Device: Mepilex® Border Ag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbial load reduction
The relative reduction from baseline in microbial load (bio-burden) over a 2 week study period as measured by quantitative and qualitative microbiology methods.
Measured: Days 1 and 14
Secondary outcomes (2)
clinical evolution of the wound (presence of each of the selected clinical signs)
Study's clinical signs: level of exudate (moderate or heavy at baseline), pain between 2 dressing changes, peri-ulcer skin erythema, oedema, foul odour
Measured: Days 1, 3, 7, 14
Occurrence of adverse events
Measured: Day 1-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg UlcersStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Keith Harding, Principal investigator, Cardiff University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427491
- Sponsor's protocol ID
- CW-0142-11-U358
- Status last verified
- Jul 2013
- First submitted
- 23 Aug 2011
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Comparative Clinical Study to Compare Aquacel® Ag vs. Mepilex® Border Ag to Manage Bioburden in Leg Ulcers.
- ClinicalTrials.gov ID
- NCT01427491
- Acronym / sponsor ID
- CW-0142-11-U358
- Conditions
- Leg Ulcers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 1 Sep 2011 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquacel® Ag | Active comparator | Device: Aquacel® Ag |
| Mepilex® Border Ag | Active comparator | Device: Mepilex® Border Ag |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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® AgDressing 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. | Device | Aquacel® Ag |
| Mepilex® Border AgDressing 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. | Device | Mepilex® Border Ag |
Primary outcome
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.
2 secondary outcomes
clinical evolution of the wound (presence of each of the selected clinical signs)
Time frame: Days 1, 3, 7, 14
Occurrence of adverse events
Time frame: Day 1-14
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 30 Jul 2013.
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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.
Keith Harding principal investigator
Cardiff University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aquacel® Ag and Mepilex® Border Ag in people with Leg Ulcers, run by ConvaTec Inc. at 3 sites 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 5 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 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Microbial load reduction (time frame: Days 1 and 14). 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 30 Jul 2013.