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

NCT03757143 | Completed Phase 4

• 1 other identifier: CLEAN3
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Intravascular-catheter Colonization; Catheter Failure

Keywords

Skin antisepsis; Chlorhexidine; Povidone Iodine; Intravascular-catheter colonization; Catheter failure; Bundle of new devices

Outcome Measures

Primary Outcomes (2)

• Incidence of catheter-related infectious complications

  Incidence of catheter-related infectious complications, and include catheter colonisation, local infection and CR-BSI

  8 days

• Time between catheter insertion and catheter failure

  Time between catheter insertion and catheter failure: defined as any premature removal of PVC before end of treatment, other than for routine replacement, and includes phlebitis, infiltration, occlusion, accidental catheter removal, local infection and CR-BSI whichever occurred first

  8 days

Secondary Outcomes (15)

• Number of phlebitis

  8 days

• Number of accidental catheter removal

  8 days

• Number of infiltration

  8 days

• Number of catheter occlusion

  8 days

• Number of CR-BSI

  8 days

Study Arms (4)

PVI et Insyte

ACTIVE COMPARATOR

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

Drug: Povidone-Iodine-Alcohol; Device: Insyte Autoguard BC Winged

CHG et Insyte

EXPERIMENTAL

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

Drug: Chlorhexidine-Alcohol; Device: Insyte Autoguard BC Winged

PVI et Nexiva

EXPERIMENTAL

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

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

CHG et Nexiva

EXPERIMENTAL

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

Drug: Chlorhexidine-Alcohol; Device: Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes

Interventions

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

Pose of Nexiva single port catheter

CHG et Nexiva; PVI et Nexiva

Povidone-Iodine-Alcohol DRUG

Povidone-Iodine-Alcohol will be used to disinfect the skin

PVI et Insyte; PVI et Nexiva

Chlorhexidine-Alcohol DRUG

Chlorhexidine-Alcohol will be used to disinfect the skin

CHG et Insyte; CHG et Nexiva

Insyte Autoguard BC Winged DEVICE

Pose of Insyte Autoguard BC Winged

CHG et Insyte; PVI et Insyte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

University Hospital of Poitiers

Poitiers, 86021, France

Location

Related Publications (3)

• 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.

  PMID: 35700207 DERIVED

• 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.

  PMID: 33539734 DERIVED

• 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.

  PMID: 30944142 DERIVED

MeSH Terms

Interventions

Povidone-Iodine; Ethanol; Chlorhexidine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Alcohols; Biguanides; Guanidines; Amidines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: January 7, 2019
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

FR (1)