Study to Compare CAUTI Rates Following ERASE CAUTI Tray Silver vs Silver Coated Foley Catheters

NCT ID: NCT02915692

Last Updated: 2016-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

753 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Foley catheter is one component in a catheter insertion procedure that could contribute to a catheter associated urinary tract infection (CAUTI). Improvements in the catheter insertion procedure using the ERASE CAUTI Tray system may help to lower these infection rates.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ERASE Silver Coated Foley Catheters

Subjects given silver catheters from an ERASE CAUTI Tray.

ERASE Silver Coated Foley Catheter

Intervention Type DEVICE

Foley catheter from ERASE CAUTI Kit will be administered as required.

Comparator Silver Coated Catheter

Comparator silver urinary catheter

Comparator Silver Coated Catheter

Intervention Type DEVICE

Foley catheter coated with silver

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ERASE Silver Coated Foley Catheter

Foley catheter from ERASE CAUTI Kit will be administered as required.

Intervention Type DEVICE

Comparator Silver Coated Catheter

Foley catheter coated with silver

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Silver coated Foley catheter Silver coated catheter

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* At least 18 years of age
* Received either silver coated Foley catheter or ERASE CAUTI silver coated catheter

Exclusion Criteria

* UTI present upon current hospital admission
* Burn patients, transplant patients, or immune-compromised patients.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medline Industries

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

S T Symeonides, MD

Role: PRINCIPAL_INVESTIGATOR

Parish Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oconnee Regional Medical Center

Milledgenville, Georgia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MII-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.