- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02950246
Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation (CHLOVEPI)
Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery
Study Overview
Status
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: hakim harkouk, CCA
- Phone Number: 0033649095422
- Email: hakimharkouk@gmail.com
Study Locations
-
-
ILE DE France
-
Boulogne-Billancourt, ILE DE France, France, 92100
- Recruiting
- CHU Ambroise Paré
-
Contact:
- HARKOUK HAKIM, PHC
- Phone Number: 003349094670
- Email: hakim.harkouk@aphp.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Principal Investigator: hakim harkouk, CCA, GH Raymond Poincaré-Ambroise Paré
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPKT-213
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.
Clinical Trials on Catheter Related Infection
-
University Hospital, AngersNot yet recruitingCatheter Infection | Catheter-Related Infections | Catheter Complications | Catheter Related Complication | Catheter-related Bloodstream Infection
-
Catholic University of PelotasCompletedCatheter Related Infection
-
Hospital Nossa Senhora da ConceicaoUnknownCatheter Related InfectionBrazil
-
Poitiers University HospitalCompletedPreventing Catheter Related InfectionFrance
-
Universitaire Ziekenhuizen KU LeuvenUnknown
-
Leonard-Meron Biosciences, Inc.RecruitingCatheter-related InfectionsUnited States, Puerto Rico
-
Abant Izzet Baysal UniversityNot yet recruitingCatheter Infection | Catheter Infections Related
-
Hospital General Universitario Gregorio MarañonTerminated
-
Zonguldak Ataturk State HospitalSisli Hamidiye Etfal Training and Research Hospital; Cumhuriyet UniversityCompletedCatheter Infection | Catheter-Related Infections | Catheter Blockage | Dialysis Catheter; Thrombosis | Catheter Related Complication | Catheter DysfunctionTurkey
-
The University of QueenslandQueensland Children's Hospital; Griffith University; Royal Brisbane and Women... and other collaboratorsRecruitingWound Infection | Catheter Infection | Catheter-Related Infections | Wound | Vascular Access Complication | Catheter Complications | Device Related Infection | Wound of Skin | Catheter Related Complication | Device Related Sepsis | Occlusive Dressings | Device Site ReactionsAustralia, France
Clinical Trials on perineural catheterization implementation
-
Centre hospitalier de l'Université de Montréal...CompletedTotal Knee ArthroplastyCanada
-
University Hospital, GrenobleCompleted
-
Atrium Medical CenterMaastricht UniversityUnknown
-
Hospital Civil de GuadalajaraInstituto Jalisciense de CancerologiaRecruiting
-
University Hospital, RouenCompletedBacterial ColonizationFrance
-
Zhejiang Cancer HospitalCompletedUterine Cervical NeoplasmsChina
-
Abington Memorial HospitalUnknownPostoperative BacteriuriaUnited States
-
Catharina Ziekenhuis EindhovenEindhoven University of TechnologyCompletedCatheter Related Complication | Ultrasound; ComplicationsNetherlands
-
Shiraz University of Medical SciencesCompletedEmbolism | Cardiac Catheterization | RetinaIran, Islamic Republic of