Evidence map›Paper›PMID 25728152›Full record

Trial reportAmerican journal of infection control2015

Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial.

Anne-Marie Leuck, James R Johnson, Matthew A Hunt, Kush Dhody, Kazem Kazempour, Patricia Ferrieri, Susan Kline

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in American journal of infection control, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
2.4field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 32 citations in OpenAlex.

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  10. Value of surgical pilot and feasibility study protocols.The British journal of surgery · 2019
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 1 institution in 1 country.

Anne-Marie LeuckDepartment of Medicine, University of Minnesota, Minneapolis, MN. Electronic address: leuck002@umn.edu.
James R JohnsonDepartment of Medicine, University of Minnesota, Minneapolis, MN; Department of Medicine, Veterans Affairs Healthcare System, Minneapolis, MN.
Matthew A HuntDepartment of Neurosurgery, University of Minnesota, Minneapolis, MN.
Kush DhodyAmarex Clinical Research, Germantown, MD.
Kazem KazempourAmarex Clinical Research, Germantown, MD.
Patricia FerrieriDepartment of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN; Department of Pediatrics, University of Minnesota, Minneapolis, MN.
Susan KlineDepartment of Medicine, University of Minnesota, Minneapolis, MN.
University of Minnesota · US

Funding

University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
Infectious Disease Training in Clinical InvestigationT32AI055433 · NIAID · UNIVERSITY OF MINNESOTA TWIN CITIES · PI David R Boulware · 2003 to 2026
$6.1M
A Total Infection Control Foley Catheter SystemR44DK055891 · NIDDK · INNOVATIVE CHEMICAL/ENVIRONMENTAL TECH · PI SARANGAPANI, SHANTHA S · 2000 to 2008
$2.7M
Gut reservoir of E. coli ST131I01CX000920 · VA · MINNEAPOLIS VA MEDICAL CENTER · PI JOHNSON, JAMES R · 2014 to 2021
–
CSRD VA I01 CX000920NCATS NIH HHS UL1 TR000114NIAID NIH HHS 5T32AI055433-09NIAID NIH HHS T32 AI055433NIDDK NIH HHS R44 DK055891NIDDK NIH HHS R44 DK55891-06
6 · The paper itself

Abstract

backgroundThe purpose of this study was to evaluate the safety of a novel silver-impregnated Foley catheter system designed to prevent catheter-associated bacteriuria and funguria, assess recruitment feasibility for a future pivotal trial, and preliminarily assess efficacy.

methodsThis single-center, randomized controlled trial at a university hospital involved adult neurosurgical patients expected to have a urinary catheter for ≥24 hours. Subjects were randomized to a novel silver-impregnated (test) Foley catheter system or a control system. They were followed for 30 days (or until discharge) while catheterized and for up to 48 hours after catheter removal, with daily bacteriuria testing and assessment for symptoms of infection and catheter intolerance.

resultsNinety-five subjects were randomized (intention-to-treat [ITT] population). Of these, 61 subjects (64%) had a catheter for ≥24 hours without perioperative antibiotics beyond 24 hours (evaluable population). In the ITT population, 11 of 95 (12%) subjects had an asymptomatic bacteriuria (ABU) event. Compared with controls, test system recipients had a trend toward longer time to ABU in the ITT population (P = .08, log-rank test) and a longer time to ABU in the evaluable population (P = .03). All 6 ABU events caused by gram-negative bacilli occurred in the control group.

conclusionIn this pilot randomized trial the test system was well tolerated and seemingly effective in preventing catheter-associated bacteriuria, especially with gram-negative bacilli. A pivotal study is warranted.

Indexed as

Urinary CathetersAdolescentAdultAgedAged, 80 and overAnti-Infective AgentsBacterial InfectionsCatheter-Related InfectionsCoated Materials, BiocompatibleFemaleHospitals, UniversityHumansMaleMiddle AgedMycosesPilot ProjectsAnti-Infective AgentsCoated Materials, BiocompatibleSilverCatheter-associated bacteriuriaFoley catheterIonic silverUrinary tract infection

Identifiers

PMID25728152
PMCPMC5540320
OpenAlexW2078761104

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.