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

Hôpital Raymond Poincaré

Status: Unknown

Conditions: Infection of Catheter Exit Site; Catheter Related Infection

Treatments: Drug: 2% alcoholic chlorhexidine; Drug: povidon iodine; Procedure: perineural catheterization implementation

Study type: Interventional

Funder types: Other

Identifiers

NCT02950246

CPKT-213

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 92 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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92 participants in 2 patient groups

2% alcoholic chlorhexidine group

Experimental group

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

Treatment:

Procedure: perineural catheterization implementation

Drug: 2% alcoholic chlorhexidine

povidon iodine group

Active Comparator group

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

Treatment:

Procedure: perineural catheterization implementation

Drug: povidon iodine