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Completed

NCT Number: NCT05712434

Chlorhexidine to Prevent Catheter-related Urinary Tract Infection

The study is to investigate whether chlorhexidine (CHG)-based antiseptics is more effective to prevent catheter-related urinary tract infection (CAUTI) among inhospital patients who required Foley catheter insertion. This is a cluster-randomised, step-wedged clinical trial, in which every participated unit will used three different Foley catheter insertion protocols during the study period:

1. Iodine protocol: using 10% povidone-iodine as the primary antiseptic during Foley insertion. This is the routine practice before this study in the participated hospital, as well as many Taiwanese hospitals. 2. CHG protocol: instead of povidone-iodine solution, use 2% aqueous CHG solution as the primary disinfectant during Foley solution. 3. CHG plus protocol: additional to 2% CHG solution, added 0.5% CHG impregnated gel as the lubrication during Foley insertion.

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Key information

Conditions

Urinary Tract Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

This is a open-labelled, cluster-randomized, step-wedged clinical trial aimed to observe the incidence if CAUTI during the designated study period (12 months for all participated units). All included units will start with the iodine protocol, which is the standard practice in the hospital, and then switched to CHG protocol than CHG plus protocol according to the results of randomization. Each unit will be randomized in to three different groups (A, B, and C):

Group A) 2 months of iodine protocol, followed by 4 months of CHG protocol, followed by 6 months of CHG plus protocol.

Group B) 4 months of iodine protocol, followed by 4 months of CHG protocol, followed by 4 months of CHG plus protocol.

Group C) 6 months of iodine protocol, followed by 4 months of CHG protocol, followed by 2 months of CHG plus protocol.

All unit will be monitored and compared for the occurrence of CAUTI, which is defined in accordance to the definition from the National Healthcare Safety Network (USCDC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

This is a cluster-randomized clinical trial. The enrollment is for healthcare units (wards, ICUs) in the participated hospitals rather than individuals. Patients who were admitted in the included unit with be enrolled in our study automatically.

Inclusion criteria

(for units):

  • Adult acute care wards or intensive care units, which primarily care for adult patients aged above 18 years.
  • Currently not using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
  • Had patients who required Foley catheter insertion during the last 12 months prior to inclusion.
  • Willing to implant measures to improve the rate of CAUTI, and to participate and follow the study protocol in our study.

Exclusion criteria

(for units):

  • Units currently using chlorhexidine as disinfectants for Foley catheter insertion or routine care.
  • Wards or intensive care units with patients aged below 18 years of age in their routine practice.

Treatment and study plan

Long Intervention

Other

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 2 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 6-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other names: 4-month CHG and 6-month CHG plus

Mid-length Intervention

Other

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 4 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 4-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other names: 4-month CHG and 4-month CHG plus

Short Intervention

Other

Each unit will start with iodine protocol, which uses 10% povidone-iodine for disinfection during Foley insertion, for 6 months. After the designated duration of protocol (determined by the results of randomization), each unit will than switched to CHG protocol for 4 months, in which 2% aqueous chlorhexidine solution are used instead of iodine solution. Subsequently, in the final 2-month phase of study, each unit will than switched to CHG plus protocol, in which 0.05% CHG impregnated gel will be used alongside 2% CHG solution during Foley insertion.

Other names: 4-month CHG and 2-month CHG plus

Primary outcomes

  1. Incidence of catheter-related urinary tract infection

    Time frame: During the entire observation period (12 months)

    The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network (any Candida species will be excluded as pathogen)

Secondary outcomes

  1. Incidence of catheter-related urinary tract infection (including candiduria)

    Time frame: During the entire observation period (12 months)

    The incidence of CAUTI, according to the updated definition of National Healthcare Safety Network, but candiduria not excluded as pathogen

  2. Incidence of catheter-related urinary tract infection, by different clinical relevant isolates

    Time frame: During the entire observation period (12 months)

    The incidence of CAUTI caused by different clinical relevant isolates (Pseudomonas aeruginosa, enterococci, enteric gram-negative bacteria, other pseudomonads, etc.)

Other outcomes

  1. The occurrence of severe adverse effects related to topical CHG disinfection

    Time frame: During the entire observation period (12 months)

    The occurrence of severe adverse effects related to topical CHG disinfection

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Hualien Tzu Chi General Hospital
  • Lotung Poh-Ai Hospital
  • Min-Sheng General Hospital
  • National Taiwan University Hospital Hsin-Chu Branch
  • National Taiwan University Hospital, Yun-Lin Branch

Registry information

Official study title

A Multi-center, Stepped-wedge, Cluster-randomized Control Trial to Evaluation the Effectiveness of Chlorhexidine to Prevent Catheter-associated Urinary Tract Infection

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 3, 2023
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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