Effectiveness and safety of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients: A randomized controlled trial
Abstract
BACKGROUND
Clinical practice guidelines for the prevention of catheter associated urinary tract infection (CAUTI) recommend urinary catheter securement in critical patients although there is scant research on its effectiveness.
AIM
To analyse whether securement of an indwelling urinary catheter (IUC) reduces the risk of CAUTI and meatal pressure injury among intensive care unit (ICU) patients and assess medical adhesive-related skin injury (MARSI) associated with the securement device.
STUDY DESIGN
Open randomized controlled trial involving patients admitted to two ICUs in Spain. In the intervention group (n = 169 patients), the IUC was secured to the thigh using an in-house device piloted as part of this trial. Controls (n = 181) received standard care, including non-securement of the IUC. Barrier film spray was applied to the securement site with the aim of preventing MARSI. The definitions of the main outcomes were: CAUTI was diagnosed according to the criteria of the European Centre for Disease Prevention and Control, meatal pressure injury was categorized into four grades and MARSI was classified as either erythema or skin tears. Bivariate analysis and multivariate logistic regression were performed. Log-rank and Cox regressions were used to compare risk over time to CAUTI and meatal pressure injury in the two groups.
RESULTS
Data from 350 patients were analysed, 169 (48.29%) from IG and 181 (51.71%) from CG. In the multiple logistic regression analysis, IUC securement…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 350 participants or records.
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