Clinical trial NCT02950246: Alcoholic Chlorhexidine Compared to Povidone Iodine to Limit Perineural Catheter Colonisation
Official title: Effect of 2% Alcoholic Chlorhexidine Compared to Povidone Iodine Solution to Limit Colonisation After Perineural Catheterization in Orthopaedic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infection of Catheter Exit Site
Catheter Related Infection
Lead sponsor: Hôpital Raymond Poincaré
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: perineural catheter colonization reduction
timeFrame: 24 months
Secondary outcomes:
measure: perineural catheter infection
timeFrame: 24 months
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Chu Ambroise Pare
state: ILE DE France
Study officials:
affiliation: GH Raymond Poincaré-Ambroise Paré
name: hakim harkouk, CCA
role: PRINCIPAL_INVESTIGATOR
References:
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.