NCT02950246

Brief Summary

Implementation of perineural catheters may lead to infection by catheter colonization. Catheters may be colonized by the bacteria present on the skin. This is most often commensal organisms as Staphylococcus or gram negative bacilli. In a large study of 1416 peripheral nerve catheters, 28.7% of catheters were cultured positive. This colonization is most often silent because in the same study only 3% of patients had signs of local inflammation and one psoas abscess was observed (0.07%). The germs are most often coagulase negative staphylococci (61%) and gram negative bacillus (21.6%).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.7 years

First QC Date

January 20, 2016

Last Update Submit

July 17, 2018

Conditions

Infection of Catheter Exit SiteCatheter Related Infection

Outcome Measures

Primary Outcomes (1)

  • perineural catheter colonization reduction

    Assuming a frequency of the event without treatment 40%, to highlight a sub treatment relative reduction in frequency of 80% it is necessary to include 92 patients (for a 90% power and a alpha risk of 1%). According to the technique of Brun-Buisson, the catheter will be collected in a neutral tube containing 1 ml of sterile saline. In the laboratory, the tube will be vortexed for one minute and then 10μl of the sample will be seeded in oese calibrated on blood agar. Reading culture will be achieved after 48 hours at 35 ° C aerobically. The catheter will be considered settled if the count found most 1000 UFC / ml. Bacterial identification will be carried out by mass spectrometry and sensitivity by the diffusion method on Muller-Hinton agar. If there is more than one bacterial population, the number of PDUs for each bacterium was determined. In this case, we will consider only the bacterial types\> 1000 UFC / ml

    24 months

Secondary Outcomes (1)

  • perineural catheter infection

    24 months

Study Arms (2)

2% alcoholic chlorhexidine group

EXPERIMENTAL

Skin preparation Use of 10 ml of 2% alcoholic Chlorhexidine "drug" for disinfection in place of povidone iodine without scrubing "device" Wait at least 30 secondes for drying Perineural catheterization implementation Ultrasonography use

Procedure: perineural catheterization implementationDrug: 2% alcoholic chlorhexidine

povidon iodine group

ACTIVE COMPARATOR

Skin preparation Use of 10 ml of povidone iodine "drug" for disinfection with scrubing "device" Wait at least 30 seondes for drying Perineural catheterization implementation Ultrasonography use

Procedure: perineural catheterization implementationDrug: povidon iodine

Interventions

perineural catheterization implementationPROCEDURE

Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use

2% alcoholic chlorhexidine grouppovidon iodine group
2% alcoholic chlorhexidineDRUG
2% alcoholic chlorhexidine group
povidon iodineDRUG
povidon iodine group

Eligibility Criteria

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

You may qualify if:

  • Patient classified I, II or III by the American Society of Anesthesiology
  • Perineural catheterization use for pain management
  • Patient should have an orthopaedic surgery

You may not qualify if:

  • An allergy to povidone iodine
  • An allergy to alcoholic Chlorhexidine 2%
  • Pregnant women
  • Breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Ambroise Pare

Boulogne-Billancourt, Île-de-France Region, 92100, France

RECRUITING

Related Publications (1)

  • Harkouk H, Thibault-Sogorb T, Beauchet A, Espinasse F, Lawrence C, Martinez V, Fletcher D. Two per cent alcoholic chlorhexidine versus alcoholic five per cent povidone-iodine for the prevention of perineural catheter colonisation: The CHLOVEPI randomised, controlled trial. Anaesth Crit Care Pain Med. 2021 Feb;40(1):100790. doi: 10.1016/j.accpm.2020.100790. Epub 2020 Dec 5.

    PMID: 33285282DERIVED

MeSH Terms

Conditions

Catheter-Related Infections

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • hakim harkouk, CCA

    GH Raymond Poincaré-Ambroise Paré

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hakim harkouk, CCA

CONTACT

0033649095422hakimharkouk@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical assistant chief

Study Record Dates

First Submitted

January 20, 2016

First Posted

November 1, 2016

Study Start

November 1, 2016

Primary Completion

July 15, 2018

Study Completion

November 1, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations

FR(1)