Efficacy of securing urinary catheter in the reduction of urinary tract infections in the critical patients

Effectiveness and safety profile of a simple catheter securement device aimed at preventing catheter-associated urinary tract infection in intensive care unit patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11342326

Enrollment

598

Registered

2023-11-06

Start date

2017-09-01

Completion date

Unknown

Last updated

2023-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter Associated Urinary Tract Infetion (CAUTI) Meatal Pressure Injuries Infections and Infestations

Interventions

Patients in the Control Group received care as usual, which included non-securement of the urinary catheter. In the Intervention Group, the urinary catheter was secured to the thigh using a simple in-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. Expected duration of the urinary catheter and length of stay in the intensive care unit >48 hours 3. Urinary catheter inserted in the intensive care unit or in the operating room 4. Signed informed consent

Exclusion criteria

Exclusion criteria: 1. Securing not possible 2. Urinary infection or suspicion on admission 3. Allergy to adhesive tape 4. Urinary or prostatic pathology

Design outcomes

Primary

Measure	Time frame
Catheter-associated Urinary Tract Infection measured every 12 hours. A urinary Tract Infection was diagnosed according to the criteria of the European Centre for Disease Prevention and Control, namely at least one of the following symptoms with no other recognised cause: fever (> 38 °C), urgency, frequency, dysuria or suprapubic tenderness – and a positive urine culture, i.e. = 105 microorganisms per ml of urine with no more than two species of microorganisms. Data from this variable were collected reviewing patient notes.	—

Measure

Time frame

Catheter-associated Urinary Tract Infection measured every 12 hours. A urinary Tract Infection was diagnosed according to the criteria of the European Centre for Disease Prevention and Control, namely at least one of the following symptoms with no other recognised cause: fever (> 38 °C), urgency, frequency, dysuria or suprapubic tenderness – and a positive urine culture, i.e. = 105 microorganisms per ml of urine with no more than two species of microorganisms. Data from this variable were collected reviewing patient notes.

—

Secondary

Measure	Time frame
Meatal pressure injury categorized according to the 1–4 grade classification system of the EPUAP–European Pressure Ulcer Advisory Panel. Data from this variable were collected by direct observation every 12 hours.	—

Countries

Spain

Contacts

Public ContactNeus Calpe Damians

neuscalpe@uic.es+34 935 04 20 00

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026