search
Back to results

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

Primary Purpose

Infection of Catheter Exit Site, Catheter Related Infection

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
perineural catheterization implementation
2% alcoholic chlorhexidine
povidon iodine
Sponsored by
Hôpital Raymond Poincaré
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Infection of Catheter Exit Site

Eligibility Criteria

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

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

Sites / Locations

  • Chu Ambroise PareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

2% alcoholic chlorhexidine group

povidon iodine group

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

perineural catheter infection
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

Full Information

First Posted
January 20, 2016
Last Updated
July 17, 2018
Sponsor
Hôpital Raymond Poincaré
search

1. Study Identification

Unique Protocol Identification Number
NCT02950246
Brief Title
Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation
Acronym
CHLOVEPI
Official Title
Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
November 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Raymond Poincaré

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection of Catheter Exit Site, Catheter Related Infection

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
92 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2% alcoholic chlorhexidine group
Arm Type
Experimental
Arm Description
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
Arm Title
povidon iodine group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
perineural catheterization implementation
Intervention Description
Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use
Intervention Type
Drug
Intervention Name(s)
2% alcoholic chlorhexidine
Intervention Type
Drug
Intervention Name(s)
povidon iodine
Primary Outcome Measure Information:
Title
perineural catheter colonization reduction
Description
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
Time Frame
24 months
Secondary Outcome Measure Information:
Title
perineural catheter infection
Description
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
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hakim harkouk, CCA
Phone
0033649095422
Email
hakimharkouk@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hakim harkouk, CCA
Organizational Affiliation
GH Raymond Poincaré-Ambroise Paré
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Ambroise Pare
City
Boulogne-Billancourt
State/Province
ILE DE France
ZIP/Postal Code
92100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HARKOUK HAKIM, PHC
Phone
003349094670
Email
hakim.harkouk@aphp.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
33285282
Citation
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.
Results Reference
derived

Learn more about this trial

Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation

We'll reach out to this number within 24 hrs