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 (CLEAN3)

Poitiers University Hospital

Status and phase: Completed; Phase 4

Conditions: Intravascular-catheter Colonization; Catheter Failure

Treatments: Drug: Chlorhexidine-Alcohol; Drug: Povidone-Iodine-Alcohol; Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes; Device: Insyte Autoguard BC Winged

Study type: Interventional

Funder types: Other

Identifiers

NCT03757143

CLEAN3

Details and patient eligibility

About

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).

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 4 patient groups

PVI et Insyte

Active Comparator group

Description:

Groupe A: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) InsyteTM AutoguardTM BC Winged, BD

Treatment:

Drug: Povidone-Iodine-Alcohol

Device: Insyte Autoguard BC Winged

CHG et Insyte

Experimental group

Description:

Groupe B: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) InsyteTM AutoguardTM BC Winged, BD

Treatment:

Device: Insyte Autoguard BC Winged

Drug: Chlorhexidine-Alcohol

PVI et Nexiva

Experimental group

Description:

Groupe C: (1) 5% (w/v) PVI-69% (v/v) ethanol (Bétadine alcoolique™, MEDA Pharma SAS); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, , PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD

Treatment:

Drug: Povidone-Iodine-Alcohol

Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes

CHG et Nexiva

Experimental group

Description:

Groupe D: (1) 2% (w/v) CHG-70% (v/v) isopropanol (ChloraPrep™, CareFusion); (2) NexivaTM single port catheter, MaxZeroTM needleless connector, PureHub™ Desinfecting Caps, PosiflushTM prefilled saline syringes, all from BD

Treatment:

Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes

Drug: Chlorhexidine-Alcohol