Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infection of Catheter Exit Site, Catheter Related Infection

Intervention / Treatment
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* Procedure: perineural catheterization implementation
* Drug: 2% alcoholic chlorhexidine
* Drug: povidon iodine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% alcoholic chlorhexidine group<br>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 implementation<br>* Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use<br>Drug: 2% alcoholic chlorhexidine<br> <br> |
| Active Comparator: povidon iodine group<br>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 implementation<br>* Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use<br>Drug: povidon iodine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 24 months |