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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Switzerland1 site
  • Balgrist University Hospital

    Zurich, 8008

Other trials in Switzerland

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.

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 groups in NCT02599181
Study groupRoleWhat they receive
WITH-Group: alcoholic skin disinfectionExperimentalIn 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 desinfectionNo interventionIn 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted6 Nov 2015 (estimated)
  2. Study startJan 2013
  3. Primary completionJan 2014
  4. Study completionMay 2014

Resources

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)
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

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.

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