NCT02599181

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 6, 2015

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1 year

First QC Date

September 20, 2015

Last Update Submit

May 29, 2017

Conditions

Catheter Infection

Keywords

Perineural cathetherCatheter infection

Outcome Measures

Primary Outcomes (1)

  • Bacteria detection

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

    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)

    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)

    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)

    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)

    After removal of PNC 72h after its insertion until one week after PNC-removal

Study Arms (2)

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.

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.

Interventions

propanol-biphenol: KodanOTHER

WITH-group, the skin is disinfected with an aerosolized alcoholic solutionpropanol-biphenol: Kodan, Schülke \& Mayr, Zurich, Switzerland.

WITH-Group: alcoholic skin disinfection

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent, surgery with perineural catheters

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

Study Officials

  • Alain Borgeat, Prof. MD

    Balgrist University Hospital, Zurich

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2015

First Posted

November 6, 2015

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

May 1, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

CH(1)