کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5867275 1563475 2015 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Major articleSafety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: A pilot randomized clinical trial
ترجمه فارسی عنوان
مقاله مهم: ایمنی و کارآیی یک کاتتر ادراری جدید برای برداشتن باکتریوری مرتبط با کاتتر: یک کارآزمایی بالینی تصادفی خلبان
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی میکروب شناسی
چکیده انگلیسی


- We present a pilot randomized controlled trial to evaluate a novel Foley catheter.
- Novel silver catheter system includes an antimicrobial matrix and antireflux valve.
- Test system was tolerated and seemingly effective in preventing bacteriuria.
- Test system seemed especially effective against gram-negative bacilli.
- A pivotal study is warranted.

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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: American Journal of Infection Control - Volume 43, Issue 3, 1 March 2015, Pages 260-265
نویسندگان
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