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Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters

Primary Purpose

Catheter Infection

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
propanol-biphenol: Kodan
Sponsored by
Balgrist University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catheter Infection focused on measuring Perineural cathether, Catheter infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

Written informed consent, surgery with perineural catheters

Exclusion criteria:

diabetes mellitus, medication with immunosuppressant drugs or any other immune-compromising illness

Sites / Locations

  • Balgrist University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

WITH-Group: alcoholic skin disinfection

WITHOUT: no alcoholic skin desinfection

Arm Description

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.

In the "WITHOUT-group", the skin is NOT disinfected prior to perineural catheter removal.

Outcomes

Primary Outcome Measures

Bacteria detection
The reduction of the PNC-colonization rate depending on the removal technique (with or without previous skin disinfection)

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
September 20, 2015
Last Updated
May 29, 2017
Sponsor
Balgrist University Hospital
Collaborators
University Hospital, Zürich
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1. Study Identification

Unique Protocol Identification Number
NCT02599181
Brief Title
Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters
Official Title
Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Balgrist University Hospital
Collaborators
University Hospital, Zürich

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Infection
Keywords
Perineural cathether, Catheter infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WITH-Group: alcoholic skin disinfection
Arm Type
Experimental
Arm Description
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.
Arm Title
WITHOUT: no alcoholic skin desinfection
Arm Type
No Intervention
Arm Description
In the "WITHOUT-group", the skin is NOT disinfected prior to perineural catheter removal.
Intervention Type
Other
Intervention Name(s)
propanol-biphenol: Kodan
Intervention Description
WITH-group, the skin is disinfected with an aerosolized alcoholic solutionpropanol-biphenol: Kodan, Schülke & Mayr, Zurich, Switzerland.
Primary Outcome Measure Information:
Title
Bacteria detection
Description
The reduction of the PNC-colonization rate depending on the removal technique (with or without previous skin disinfection)
Time Frame
After removal of PNC 72h after its insertion
Secondary Outcome Measure Information:
Title
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)
Description
correlation between the Perineural-colonization and clinical signs of local inflammation at the puncture site
Time Frame
After removal of PNC 72h after its insertion until one week after PNC-removal
Title
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)
Description
correlation between the Perineural-colonization and clinical signs of local
Time Frame
After removal of PNC 72h after its insertion until one week after PNC-removal
Title
negative predictive value: all testing negative and no clinical signs of local infection / all testing negative (no unit)
Description
correlation between the Perineural-colonization and clinical signs of local
Time Frame
After removal of PNC 72h after its insertion until one week after PNC-removal
Title
Positive predictive value: all testing positive and with clinically infection / all testing positive (no unit)
Description
correlation between the Perineural-colonization and clinical signs of local
Time Frame
After removal of PNC 72h after its insertion until one week after PNC-removal

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Written informed consent, surgery with perineural catheters Exclusion criteria: diabetes mellitus, medication with immunosuppressant drugs or any other immune-compromising illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Borgeat, Prof. MD
Organizational Affiliation
Balgrist University Hospital, Zurich
Official's Role
Study Director
Facility Information:
Facility Name
Balgrist University Hospital
City
Zurich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

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Local Inflammation Does Not Correlate With Bacterial Colonization and Contamination of Perineural Catheters

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