Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation

Catheter Related Infection Clinical Trial

— CHLOVEPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02950246
• Other study ID #: CPKT-213
• Status: Recruiting
• Phase: N/A
• Start date: November 2016
• Est. completion date: November 2018

Study information

• Verified date: July 2018
• Source: Hôpital Raymond Poincaré
• Contact: hakim harkouk, CCA
• Phone: 0033649095422
• Email: hakimharkouk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: November 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheter Related Infection
• Catheter-Related Infections
• Communicable Diseases
• Infection
• Infection of Catheter Exit Site

Intervention

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

Drug:
• 2% alcoholic chlorhexidine

• povidon iodine

Locations

Country	Name	City	State
France	Chu Ambroise Pare	Boulogne-Billancourt	ILE DE France

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Raymond Poincaré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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