Urinary Tract InfectionNCT01054690
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)
A study testing Bactiguard Infection Protection (BIP) Cathter. and Silicone Urinary Catheter in people with Urinary Tract Infection, run by Region Skane at 3 sites in Sweden.
Trial summary
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection
- What is being tested?
- Bactiguard Infection Protection (BIP) Cathter. and Silicone Urinary Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 511 participants
- Where
- 3 sitesSweden
- Study dates
- Oct 2008to Aug 2009
- 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
- Adults in elective surgery requiring urinary catheterization
Who cannot join
- Patients who has or recently (within 3 weeks) had a urinary catheter
- Signs of urinary tracts infection
- Previous radiation therapy in lower pelvis
- Latex allergy
- Cognitive impaired
- Do not understand Swedish language.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Ortopedkliniken, Hässleholms Sjukhus
Hässleholm, 281 25
Ortopedklinien, Lunds Hospital
Lund, 221 85
Ortopedkliniken Lasarettet i Trelleborg
Trelleborg, 231 52
About this study
Official title: A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).
- Conditions
- Urinary Tract Infection
- Being tested
- Bactiguard Infection Protection (BIP) Cathter., Silicone Urinary Catheter
- Keywords
- Catheterization, Urinary Tract Infection, Elective Surgery
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bactiguard Infection Protection (BIP) Cathter.Device
Silicone Urinary CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Silver alloyed urinary catheter | Experimental | Not described Receives: Device: Bactiguard Infection Protection (BIP) Cathter. |
| Silicone urinary catheter | Placebo comparator | Not described Receives: Device: Silicone Urinary Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.
Measured: At catheter withdrawal (normally 1-3 days after catheter insertion).
Secondary outcomes (1)
Patient´s evaluation of the catheterization and overall satisfaction.
Measured: At catheter withdrawal and 7-10 days after catheter withdrawal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startOct 2008
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Bactiguard AB, Sweden
- Investigators
- Karin Stenzelius, PhD Nurse, Principal investigator, Department Urology, University Hospital in Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054690
- Sponsor's protocol ID
- H15 315/2007
- Status last verified
- Jan 2010
- First submitted
- 14 Jan 2010
- Last updated
- 22 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT01054690
- Acronym / sponsor ID
- H15 315/2007
- Conditions
- Urinary Tract Infection
- Keywords
- Catheterization, Urinary Tract Infection, Elective Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Bactiguard AB, Sweden
- Study start
- Oct 2008
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jan 2010 (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.
This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver alloyed urinary catheter | Experimental | Device: Bactiguard Infection Protection (BIP) Cathter. |
| Silicone urinary catheter | Placebo comparator | Device: Silicone Urinary Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults in elective surgery requiring urinary catheterization
Key exclusion criteria (6 listed)
- Patients who has or recently (within 3 weeks) had a urinary catheter
- Signs of urinary tracts infection
- Previous radiation therapy in lower pelvis
- Latex allergy
- Cognitive impaired
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 |
|---|---|---|
| Bactiguard Infection Protection (BIP) Cathter. | Device | Silver alloyed urinary catheter |
| Silicone Urinary Catheter | Device | Silicone urinary catheter |
Primary outcome
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.
Time frame: At catheter withdrawal (normally 1-3 days after catheter insertion).
1 secondary outcome
Patient´s evaluation of the catheterization and overall satisfaction.
Time frame: At catheter withdrawal and 7-10 days after catheter withdrawal.
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 22 Jan 2010.
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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.
Karin Stenzelius, PhD Nurse principal investigator
Department Urology, University Hospital in Lund, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bactiguard Infection Protection (BIP) Cathter. and Silicone Urinary Catheter in people with Urinary Tract Infection, run by Region Skane at 3 sites in Sweden.
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 1 inclusion and 6 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 22 Jan 2010. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery. (time frame: At catheter withdrawal (normally 1-3 days after catheter insertion).). 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 22 Jan 2010.