Clinical trial NCT03757143: Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure
Official title: Skin Antisepsis With Chlorhexidine-Alcohol Versus Povidone Iodine-Alcohol, Combined or Not With Use of a Bundle of New Devices, for Prevention of Intravascular-catheter Colonization and Catheter Failure: An Open Label, Single Center, Randomized Controlled, Two-by-two Factorial Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intravascular-catheter Colonization
Catheter Failure
Keywords: Skin antisepsis
Chlorhexidine
Povidone Iodine
Intravascular-catheter colonization
Catheter failure
Bundle of new devices
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Short peripheral intravenous catheters (PVC) are the most frequently used invasive medical devices in hospitals. Unfortunately, PVCs often fail before the end of treatment due to the occurrence of complications, which can be mechanical, vascular or infectious. Complications lead to infusion failure and device replacement, which results in interrupted therapy, pain associated with resiting and increased health care costs for resources and staff time. Catheter related bloodstream infections (CR-BSIs) prolong hospitalization and increase treatment costs and mortality.

Prevention of these complications is based on the respect of hygiene rules and the use of bio-compatible catheters. The choice of the antiseptic solution for skin disinfection is key. Similarly, the use of new technologies such as catheters designed to minimize blood exposure, zero-reflux needleless-connectors, disinfecting caps, and flushing PVCs before and after each medication administration to maintain catheter patency are of theoretical interest, but little scientific data support their use in routine.

The primary objectives of this study are, first, to demonstrate that skin preparation with 2% chlorhexidine (CHG)-70% isopropanol decreases the risk of PVC colonization compared to skin preparation with 5% povidone iodine (PVI)-69% ethanol. Second, to demonstrate that use of a bundle of technologies including a new PVC, zero-reflux needless-connectors, disinfecting caps, and single-use prefilled flush syringes extends the time between catheter insertion and catheter failure.

The secondary objectives are to compare between the four study group incidence of phlebitis, accidental catheter removal, infiltration, catheter occlusion, CR-BSI, local infection, all-cause bloodstream infections, catheter colonization, duration of catheter remaining in place without complication, length of hospital stay, safety and patient satisfaction.

The CLEAN 3 study is an open-label, single centre, investigator-initiated, randomised, four-parallel group, two-by-two factorial trial. Patients requiring PVC for an expected 48 h will be randomised in one of four groups according to skin disinfection method and type of devices used. Randomization will be carried out through a secure web-based randomization system. Inclusions are expected to begin in January 2019 and continue until July 2019, once the number of catheters required has been reached.

Patients will be enrolled at the Emergency department of the Poitiers University Hospital before being hospitalised in one of five wards (neurology, neurology, pneumology, internal medicine and downstream emergency unit).


Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18 years) patients,
* Having clinical indication for placement of a single PVC for at least 48 hours (no minimum port access during the study duration),
* Willing and able to provide informed consent.

Exclusion Criteria:

* Known allergies to CHG, PVI, isopropanol or ethanol,
* Participation to another clinical trial aimed at reducing PVC complications,
* Suspicion of bloodstream infection at catheter insertion,
* Skin injury a catheter insertion site increasing the risk of catheter infection,
* PVC inserted extremely urgently, making it impossible to comply with the protocol,
* Intravascular catheter in place within the last 2 days, or within the last 2 weeks and with local signs of catheter complication,
* Difficult catheter insertion suspected (obesity, known IV drug users, non-visible venous network after placement of a tourniquet...),
* Patients already enrolled in this study,
* Terminal or moribund patient not expected to live more than one week,
* Patients not benefiting from a Social Security scheme or not benefiting from it through a third party,
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.
* Pregnant or breastfeeding women
* Women at age to procreate and not using effective contraception

Primary outcomes:
measure: Incidence of catheter-related infectious complications
timeFrame: 8 days
measure: Time between catheter insertion and catheter failure
timeFrame: 8 days
Secondary outcomes:
measure: Number of phlebitis
timeFrame: 8 days
measure: Number of accidental catheter removal
timeFrame: 8 days
measure: Number of infiltration
timeFrame: 8 days
measure: Number of catheter occlusion
timeFrame: 8 days
measure: Number of CR-BSI
timeFrame: 8 days
measure: Number of local infection
timeFrame: 8 days
measure: Number of all-cause bloodstream infections
timeFrame: 8 days
measure: Number of catheter colonization
timeFrame: 8 days
measure: Number of pathogens involved in catheter colonization, local infections, CR-BSI and all-cause bloodstream infections
timeFrame: 8 days
measure: Number of days the catheter remaining in place without complication
timeFrame: 8 days
measure: Length of Hospital stay censored at day 28
timeFrame: 28 days
measure: Incidence of local and systemic side effects possibly linked to antiseptic use
timeFrame: 8 days
measure: Patient's evaluation of the pain at the insertion of the catheter using visual analogue scale (VAS)
timeFrame: 8 days
measure: Patient's satisfaction at catheter removal using visual analogue scale (VAS)
timeFrame: 8 days
measure: Evaluation impact of venous line on patients' mobility at catheter removal using visual analogue scale
timeFrame: 8 days
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital of Poitiers
Study officials:
References:
citation: Maunoury F, Drugeon B, Boisson M, Marjanovic N, Couvreur R, Mimoz O, Guenezan J; CLEAN-3 Study. Cost-effectiveness analysis of bundled innovative devices versus standard approach in the prevention of unscheduled peripheral venous catheters removal due to complications in France. PLoS One. 2022 Jun 14;17(6):e0269750. doi: 10.1371/journal.pone.0269750. eCollection 2022.
citation: Guenezan J, Marjanovic N, Drugeon B, Neill RO, Liuu E, Roblot F, Palazzo P, Bironneau V, Prevost F, Paul J, Pichon M, Boisson M, Frasca D, Mimoz O; CLEAN-3 trial investigators. Chlorhexidine plus alcohol versus povidone iodine plus alcohol, combined or not with innovative devices, for prevention of short-term peripheral venous catheter infection and failure (CLEAN 3 study): an investigator-initiated, open-label, single centre, randomised-controlled, two-by-two factorial trial. Lancet Infect Dis. 2021 Jul;21(7):1038-1048. doi: 10.1016/S1473-3099(20)30738-6. Epub 2021 Feb 1.
citation: Guenezan J, Drugeon B, O'Neill R, Caillaud D, Senamaud C, Pouzet C, Seguin S, Frasca D, Mimoz O. Skin antisepsis with chlorhexidine-alcohol versus povidone iodine-alcohol, combined or not with use of a bundle of new devices, for prevention of short-term peripheral venous catheter-related infectious complications and catheter failure: an open-label, single-centre, randomised, four-parallel group, two-by-two factorial trial: CLEAN 3 protocol study. BMJ Open. 2019 Apr 2;9(4):e028549. doi: 10.1136/bmjopen-2018-028549.