Bacterial ColonizationTunnelized KTNCT01016925
Bacterial Colonization After Tunneling in Femoral Perineural Catheters
A study testing tunnelized perineural catheter in people with Bacterial Colonization, run by University Hospital, Rouen at 1 site in France.
Trial summary
Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bacterial Colonization
- What is being tested?
- tunnelized perineural catheter
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2009to Dec 2011
- 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
- Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter
Who cannot join
- Age under 18 years
- Local nerve pathology
- Refusal to regional anaesthesia
- Major psychological disorder
- Major cardiac conduction disease
- Infection at the puncture site
Trial locations and contacts
1 site in 1 country.
About this study
Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.
Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.
Read more
Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).
Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling
- Conditions
- Bacterial Colonization
- Being tested
- tunnelized perineural catheter
- Keywords
- femoral perineural catheter, tunnelization, complication, colonization, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tunnelized perineural catheterProcedure or surgery
the catheter will be tunneled 2-3 cm subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| femoral tunnelized perineural catheter | Experimental | Not described Receives: Procedure: tunnelized perineural catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of femoral perineural catheter colonization
Measured: between 24 hours and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial ColonizationStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01016925
- Sponsor's protocol ID
- 2008/065/HP
- Acronym
- Tunnelized KT
- Status last verified
- Jun 2012
- First submitted
- 19 Nov 2009
- Last updated
- 12 May 2026
- Results posted
- No
Publications
Compere V, Daccache G, Amdjar N, Fourdrinier V, Moriceau J, Foutel A, Frebourg N, Mourgeon E, Houivet E, Dureuil B. Bacterial colonization is decreased after tunneling femoral perineural catheters. Minerva Anestesiol. 2016 Dec;82(12):1288-1295. Epub 2016 Jul 26.
PubMed 27456147
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Colonization After Tunneling in Femoral Perineural Catheters
- ClinicalTrials.gov ID
- NCT01016925
- Acronym / sponsor ID
- Tunnelized KT / 2008/065/HP
- Conditions
- Bacterial Colonization
- Keywords
- femoral perineural catheter, tunnelization, complication, colonization, infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Nov 2009 (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.
Background: Bacterial colonization of peripheral nerve catheters is frequent, although infection is relatively rare. With central venous catheters, the tunneling of catheter into the subcutaneous tissue significantly decreases catheter colonization and catheter-related sepsis.
Purpose: The aim of this study is to evaluate the incidence of bacterial colonization in adult patients with femoral tunnelized perineural nerve catheters.
Methods: A total of 338 patients with femoral catheter will be included in the study. The patients will be randomized to be included in the control group (without tunnelling) or in the group with catheter tunneled 2-3 cm subcutaneously. After removal, catheter will be analyzed for colonization (primary outcome). Quantitative culture will be used as described by Brun-Buisson for intravascular catheters. The site of insertion will be monitored daily for any signs of infection (secondary outcome).
Perspective: To show the incidence of femoral perineural catheter colonization is low with subcutaneous tunneling
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| femoral tunnelized perineural catheter | Experimental | Procedure: tunnelized perineural 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)
- Patients scheduled to undergo scheduled orthopaedic surgery performed with a femoral perineural catheter
Key exclusion criteria (6 listed)
- Age under 18 years
- Local nerve pathology
- Refusal to regional anaesthesia
- Major psychological disorder
- Major cardiac conduction disease
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 |
|---|---|---|
| tunnelized perineural catheterthe catheter will be tunneled 2-3 cm subcutaneously. | Procedure or surgery | femoral tunnelized perineural catheter |
Primary outcome
incidence of femoral perineural catheter colonization
Time frame: between 24 hours and 72 hours
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 12 May 2026.
- Results publication: PubMed 27456147Compere V, Daccache G, Amdjar N, Fourdrinier V, Moriceau J, Foutel A, Frebourg N, Mourgeon E, Houivet E, Dureuil B. Bacterial colonization is decreased after tunneling femoral perineural catheters. Minerva Anestesiol. 2016 Dec;82(12):1288-1295. Epub 2016 Jul 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tunnelized perineural catheter in people with Bacterial Colonization, run by University Hospital, Rouen at 1 site in France.
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 12 May 2026. 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 France. 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?
incidence of femoral perineural catheter colonization (time frame: between 24 hours and 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01016925, which also lists 1 linked publication.
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 12 May 2026.