Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation (CHLOVEPI)

July 17, 2018 updated by: HARKOUK Hakim, Hôpital Raymond Poincaré

Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery

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%).

Study Overview

Detailed Description

Potential interest of alcoholic Chlorhexidine 2% to reduce the colonization of implanted catheters More recently, it is the antiseptic solution that has been the subject of several studies, including the latest on laying intravascular central catheters, highlights the superiority of alcoholic chlorhexidine 2% compared to povidone iodine alcohol [ 5]. Indeed, it was observed a reduction in the risk of bacterial infection 6 (RR 0 • 15, 95% CI 0 • 05-0 • 41) and of colonization by 5 (RR: 0.18 (95% Cl 0.13-0.24) through the use of alcoholic chlorhexidine with 2% applicator.

Such a study comparing the efficacy of the antiseptic (chlorhexidine vs Povidone-iodine) on the establishment of perineural catheters does not exist what motivated the establishment of our study.

Study Type

Interventional

Enrollment (Anticipated)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • ILE DE France
      • Boulogne-Billancourt, ILE DE France, France, 92100
        • Recruiting
        • CHU Ambroise Paré
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2% alcoholic chlorhexidine group
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
Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use
ACTIVE_COMPARATOR: povidon iodine group
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
Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
perineural catheter colonization reduction
Time Frame: 24 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
perineural catheter infection
Time Frame: 24 months
Clinical criteria of infection, redness of the puncture area or catheter insertion, hyperleukocytosis, CRP high level, fever, positive blood culture associated with positive catheter colonization, bacterial count > 1000 UFC/ml
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: hakim harkouk, CCA, GH Raymond Poincaré-Ambroise Paré

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (ACTUAL)

July 15, 2018

Study Completion (ANTICIPATED)

November 1, 2018

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (ESTIMATE)

November 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 18, 2018

Last Update Submitted That Met QC Criteria

July 17, 2018

Last Verified

July 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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