Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID07093437

Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study

Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-12-10

188

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

F

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Lead Sponsor

H

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating two types of devices used to secure urinary catheters in critically ill patients: adhesive devices and elastic wristband-style devices. The study aims to determine which device is more effective at preventing injuries to the urethral meatus, reducing patient discomfort, and lowering the rate of catheter-associated urinary tract infections. This is an experimental, randomized trial conducted in an Intensive Care Unit setting, addressing a significant gap in clinical guidelines and nursing practices regarding catheter securement methods. Participants will be randomly assigned to use either a commercially available adhesive device or an elastic wristband device to secure their urinary catheter on the front of the thigh. The placement is carefully chosen to allow leg movement without tension on the catheter. For adhesive devices, a protective barrier spray is applied before use, while elastic bands are adjusted to minimize movement and maintain circulation. Devices will be replaced every 72 hours or earlier if needed, alternating the thigh used for securement at each change. During the study, participants will be regularly monitored for catheter-related complications such as meatal injuries, discomfort or pain (if the patient can communicate), and urinary tract infections. Researchers will collect feedback from communicative patients about their comfort and any issues experienced. The primary outcomes are measured over an average period of 10 days. This monitoring includes clinical assessments and tracking any adverse events like catheter obstruction, skin lesions, or accidental catheter dislodgement.

CONDITIONS

Brief Title

Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Urinary catheter inserted within the past 24 hours
  • Expected catheter use longer than 48 hours
  • Estimated intensive care unit stay longer than 48 hours
Not Eligible

You will not qualify if you...

  • Known allergy to adhesive tape
  • Lesions at the urinary meatus or ongoing/suspected urinary tract infection
  • Presence of urological or prostatic pathology
  • Conditions preventing catheter securement to the thigh, such as wounds, burns, or amputations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 days

Participants receive urinary catheter securement using either adhesive or elastic wristband devices applied to the thigh to prevent catheter-associated complications.

Device replaced every 72 hours or sooner if needed with alternating thigh site

Trial Site Locations

Total: 1 location

1

Institut de Recerca Sant Pau

Barcelona, Spain, 08024

Actively Recruiting

Loading map...

Research Team

N

Neus Calpe Damians, PhD

M

Mireia Llauradó Serra, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

A Combined Treatment of Manual Therapy and Nervous Vagus Sti...

Temporomandibular Joint Disorders

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

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.

Neus Calpe-Damians, Laia Wennberg-Capellades, Arminda Ventura-Rosado...

https://pubmed.ncbi.nlm.nih.gov/38955490

Knowledge and beliefs of intensive care nurses about urinary catheter securement: Results of a national survey.

Neus Calpe-Damians, Mireia Llaurado-Serra, Laia Wennberg-Capellades

https://pubmed.ncbi.nlm.nih.gov/37977003