Catheter InfectionNCT02599181
Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters
A study testing propanol-biphenol: Kodan in people with Catheter Infection, run by Balgrist University Hospital at 1 site in Switzerland.
Trial summary
The aim of this study was to investigate the influence of alcoholic skin disin-fection before PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of the PNC or on the tip. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheter Infection
- What is being tested?
- propanol-biphenol: Kodan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2013to May 2014
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written informed consent, surgery with perineural catheters
Who cannot join
- diabetes mellitus, medication with immunosuppressant drugs or any other immune-compromising illness
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study was to investigate the influence of alcoholic skin disin-fection before PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of the PNC or on the tip. Furthermore, the correlation of bacterial colonization with PNC-associated local inflammation or infection was evaluated.
Read the detailed description
Two hundred orthopedic patients planned to receive a PNC are prospectively randomized to group PNC-removal with alcoholic skin disinfection or group PNC-removal without skin disinfection.
After standardized PNC-placement under sterile conditions, patients receive a perioperative antibiotic prophylaxis and clinical signs of local inflammation or infection are periodically recorded: The PNC were observed twice daily for clinical signs of local inflammation and local infection. Patients were also evaluated for clinical signs of systemic infection. The adhesive dressing was changed only if it became dislodged or if blood or secretions made visualization of the puncture site impossible. For the dressing change, the anaesthesiologist wore a facemask, a cap and sterile gloves.
Postoperatively, 6 hours after the initial bolus, a local anaesthetic infusion line was connected to the micro filter of the PNC. All patients received patient-controlled perineural analgesia (basal rate 5 ml/h, bolus 4 ml, lock-out time 20 min) with ropivacaine 0.3% for 24 hours, and then reduced to ropivacaine 0.2%.
PNC were removed under sterile conditions after 72h or earlier in the case of signs of infection: Removal of the PNC was performed on the surgical ward by an anaesthesiologist according to a standardized procedure: Wearing a facemask and a cap, the adhesive skin dressing was removed. In the "WITH-group", the skin was now disinfected with an aerosolized alcoholic solution (propanol-biphenol). Procedure continued after three minutes, when the skin was dry with the anaesthesiologist wearing sterile gloves and using sterile tweezers.
The distal part of the PNC (directed to the tip of the PNC) was withdrawn for 1 cm at the insertion site and then cut distally from the tweezers with a sterile pair of scissors. The distal part of the PNC was then totally withdrawn with the sterile tweezers, and with the sterile pair of scissors cut in two parts: the tip (defined as the most distal 2 cm) and the subcutaneous part, which were placed in separate dry sterile containers.
Finally, the remaining proximal part of the PNC was thrown away.
The sterile containers containing the PNC were stored at 4°C and were sent to the laboratory the same day for microbiological analysis of the PNC: The PNC were rolled onto sheep blood agar plates (Becton Dickinson BD, Basel, Switzerland) similar to the semiquantitative culture method for intravenous catheters [10] and thereafter immediately transferred to a liquid enrichment medium (thioglycolate medium, BD Basel Switzerland). Sheep blood agar was incubated for 2 days and thioglycolate for 5 days. In case of growth in the enrichment media only, an aliquot of the liquid was subcultured on solid media. Reports were considered to be positive if any growth was present. Identification of the isolated bacteria and susceptibility testing were performed according to standard methods.
All patients were observed for clinical signs of local infection at the PNC insertion site and for clinical signs of systemic infection one week after PNC-removal. For the correlation of the detection of bacteria on the PNC with clinical signs of in-flammation, the sensitivity, specificity, positive and negative predictive values were calculated on the basis of the following three categories: 1) any growth of bacteria including enrichment, 2) more or equal 5 colonies and 3) more or equal 15 colonies with the semiquantative culture technique, respectively.
- Conditions
- Catheter Infection
- Being tested
- propanol-biphenol: Kodan
- Keywords
- Perineural cathether, Catheter infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propanol-biphenol: KodanOther
WITH-group, the skin is disinfected with an aerosolized alcoholic solutionpropanol-biphenol: Kodan, Schülke \& Mayr, Zurich, Switzerland.
| Study group | Role | What they receive |
|---|---|---|
| WITH-Group: alcoholic skin disinfection | Experimental | In the WITH-group, the skin is disinfected with an aerosolized alcoholic solution propanol-biphenol: Kodan, Schülke \& Mayr, Zurich, Switzerland prior to perineural catheter removal. Receives: Other: propanol-biphenol: Kodan |
| WITHOUT: no alcoholic skin desinfection | No intervention | In the "WITHOUT-group", the skin is NOT disinfected prior to perineural catheter removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteria detection
The reduction of the PNC-colonization rate depending on the removal technique (with or without previous skin disinfection)
Measured: After removal of PNC 72h after its insertion
Secondary outcomes (4)
sensitivity: to measure the proportion of positives that are correctly identified as such (the percentage of colonized catheters which clinically show an infection). Sensitivity = all clincally positive / all catheters (no unit)
correlation between the Perineural-colonization and clinical signs of local inflammation at the puncture site
Measured: After removal of PNC 72h after its insertion until one week after PNC-removal
Specifity: measures the proportion of negatives that are correctly identified as such (the percentage of not colonized catheters which clinically do not show an infection). Specifity = all clinically negative / all catheters (no unit)
correlation between the Perineural-colonization and clinical signs of local
Measured: After removal of PNC 72h after its insertion until one week after PNC-removal
negative predictive value: all testing negative and no clinical signs of local infection / all testing negative (no unit)
correlation between the Perineural-colonization and clinical signs of local
Measured: After removal of PNC 72h after its insertion until one week after PNC-removal
Positive predictive value: all testing positive and with clinically infection / all testing positive (no unit)
correlation between the Perineural-colonization and clinical signs of local
Measured: After removal of PNC 72h after its insertion until one week after PNC-removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2015 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter InfectionStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balgrist University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Alain Borgeat, Prof. MD, Study director, Balgrist University Hospital, Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02599181
- Sponsor's protocol ID
- PNC-Inf
- Status last verified
- May 2017
- First submitted
- 20 Sep 2015
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters
- ClinicalTrials.gov ID
- NCT02599181
- Acronym / sponsor ID
- PNC-Inf
- Conditions
- Catheter Infection
- Keywords
- Perineural cathether, Catheter infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Balgrist University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Nov 2015 (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 aim of this study was to investigate the influence of alcoholic skin disin-fection before PNC (perineural catheter)-removal on the detection of bacteria on the subcutaneous part of the PNC or on the tip. Furthermore, the correlation of bacterial colonization with PNC-associated local inflammation or infection was evaluated.
Detailed description
Two hundred orthopedic patients planned to receive a PNC are prospectively randomized to group PNC-removal with alcoholic skin disinfection or group PNC-removal without skin disinfection.
After standardized PNC-placement under sterile conditions, patients receive a perioperative antibiotic prophylaxis and clinical signs of local inflammation or infection are periodically recorded: The PNC were observed twice daily for clinical signs of local inflammation and local infection. Patients were also evaluated for clinical signs of systemic infection. The adhesive dressing was changed only if it became dislodged or if blood or secretions made visualization of the puncture site impossible. For the dressing change, the anaesthesiologist wore a facemask, a cap and sterile gloves.
Postoperatively, 6 hours after the initial bolus, a local anaesthetic infusion line was connected to the micro filter of the PNC. All patients received patient-controlled perineural analgesia (basal rate 5 ml/h, bolus 4 ml, lock-out time 20 min) with ropivacaine 0.3% for 24 hours, and then reduced to ropivacaine 0.2%.
PNC were removed under sterile conditions after 72h or earlier in the case of signs of infection: Removal of the PNC was performed on the surgical ward by an anaesthesiologist according to a standardized procedure: Wearing a facemask and a cap, the adhesive skin dressing was removed. In the "WITH-group", the skin was now disinfected with an aerosolized alcoholic solution (propanol-biphenol). Procedure continued after three minutes, when the skin was dry with the anaesthesiologist wearing sterile gloves and using sterile tweezers.
The distal part of the PNC (directed to the tip of the PNC) was withdrawn for 1 cm at the insertion site and then cut distally from the tweezers with a sterile pair of scissors. The distal part of the PNC was then totally withdrawn with the sterile tweezers, and with the sterile pair of scissors cut in two parts: the tip (defined as the most distal 2 cm) and the subcutaneous part, which were placed in separate dry sterile containers.
Finally, the remaining proximal part of the PNC was thrown away.
The sterile containers containing the PNC were stored at 4°C and were sent to the laboratory the same day for microbiological analysis of the PNC: The PNC were rolled onto sheep blood agar plates (Becton Dickinson BD, Basel, Switzerland) similar to the semiquantitative culture method for intravenous catheters [10] and thereafter immediately transferred to a liquid enrichment medium (thioglycolate medium, BD Basel Switzerland). Sheep blood agar was incubated for 2 days and thioglycolate for 5 days. In case of growth in the enrichment media only, an aliquot of the liquid was subcultured on solid media. Reports were considered to be positive if any growth was present. Identification of the isolated bacteria and susceptibility testing were performed according to standard methods.
All patients were observed for clinical signs of local infection at the PNC insertion site and for clinical signs of systemic infection one week after PNC-removal. For the correlation of the detection of bacteria on the PNC with clinical signs of in-flammation, the sensitivity, specificity, positive and negative predictive values were calculated on the basis of the following three categories: 1) any growth of bacteria including enrichment, 2) more or equal 5 colonies and 3) more or equal 15 colonies with the semiquantative culture technique, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WITH-Group: alcoholic skin disinfection | Experimental | Other: propanol-biphenol: KodanIn the WITH-group, the skin is disinfected with an aerosolized alcoholic solution propanol-biphenol: Kodan, Schülke \& Mayr, Zurich, Switzerland prior to perineural catheter removal. |
| WITHOUT: no alcoholic skin desinfection | No intervention | –In the "WITHOUT-group", the skin is NOT disinfected prior to perineural catheter removal. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Written informed consent, surgery with perineural catheters
Key exclusion criteria (1 listed)
- diabetes mellitus, medication with immunosuppressant drugs or any other immune-compromising illness
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 |
|---|---|---|
| propanol-biphenol: KodanWITH-group, the skin is disinfected with an aerosolized alcoholic solutionpropanol-biphenol: Kodan, Schülke \& Mayr, Zurich, Switzerland. | Other | WITH-Group: alcoholic skin disinfection |
Primary outcome
Bacteria detection
Time frame: After removal of PNC 72h after its insertion
The reduction of the PNC-colonization rate depending on the removal technique (with or without previous skin disinfection)
4 secondary outcomes
sensitivity: to measure the proportion of positives that are correctly identified as such (the percentage of colonized catheters which clinically show an infection). Sensitivity = all clincally positive / all catheters (no unit)
Time frame: After removal of PNC 72h after its insertion until one week after PNC-removal
Specifity: measures the proportion of negatives that are correctly identified as such (the percentage of not colonized catheters which clinically do not show an infection). Specifity = all clinically negative / all catheters (no unit)
Time frame: After removal of PNC 72h after its insertion until one week after PNC-removal
negative predictive value: all testing negative and no clinical signs of local infection / all testing negative (no unit)
Time frame: After removal of PNC 72h after its insertion until one week after PNC-removal
Positive predictive value: all testing positive and with clinically infection / all testing positive (no unit)
Time frame: After removal of PNC 72h after its insertion until one week after PNC-removal
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 31 May 2017.
Related trials for Catheter Infection
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
RecruitingPhase 4
Open-Label Study to Assess Safety and Time to Catheter-related Bloodstream Infections (CRBSI) in Subjects From Birth to < 18 Years of Age
Catheter-Related Infections
Recruiting
Effectiveness of the NowCath Foley in Reducing Catheter-Associated UTIs and Blockages in Long-Term Indwelling Catheter Users (REDUCE)
Urinary Catheters, Urinary Catheterization
Not yet recruitingObservational study
Efficacy and Safety of Peripherally Inserted Central Venous Catheters
Critical Illness, Catheter-Related Infections
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.
Alain Borgeat, Prof. MD study director
Balgrist University Hospital, Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing propanol-biphenol: Kodan in people with Catheter Infection, run by Balgrist University Hospital at 1 site in Switzerland.
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 1 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 31 May 2017. 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 Switzerland. 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?
Bacteria detection (time frame: After removal of PNC 72h after its 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 31 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.