Effectiveness of Sterile Versus Clean Indwelling Catheter Care in Preventing Catheter-Associated Urinary Tract Infections at a Tertiary Care Center: A Randomized Controlled Trial.

Background Catheter-associated urinary tract infection (CAUTI) is a leading hospital-acquired infection, contributing to increased morbidity and healthcare costs. While sterile catheter care is standard, major guidelines recommend clean maintenance care, though debate continues. Objective The objective of the study is to compare the effectiveness of sterile versus clean indwelling catheter care in preventing CAUTI. Methods A participant-blind, computer-generated, stratified block randomized controlled trial was conducted at a tertiary care center. Patients with sterile baseline urine cultures were randomized to either the sterile or clean catheter care group. Data collection continued until catheter removal, hospital discharge with catheter in situ, Day 14 of catheterization, or onset of CAUTI symptoms, whichever occurred first. CAUTI symptoms including fever > 38°C, rigors, pus discharge, suprapubic pain, agitation, and confusion were monitored. The pre-specified non-inferiority margin was 12%. Analyses were performed per protocol; no intention-to-treat analysis was conducted. Results Among 346 participants, CAUTI occurred in 7.5% of the clean group and 6.9% of the sterile group (p = 0.83). Group assignment was not associated with CAUTI in adjusted analysis, while catheter duration was the strongest independent predictor (adjusted odds ratio (aOR): 1.262, 95% confidence interval (CI): 1.135-1.400). The overall incidence was 20.64 per 1,000 catheter days, with a median catheterization duration of four days in the clean group and three days in the sterile group. Pseudomonas, Klebsiella, and Escherichia coli were the most common isolates, with some showing multidrug resistance. The study was underpowered to detect small between-group differences. Conclusion Clean catheter care was comparable to sterile care in this single-center trial. While it may be a practical alternative, conclusions are limited by underpowering and methodological constraints. Larger multicenter studies with intent-to-treat analyses and adjustment for antibiotic exposure are needed to confirm these findings.