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

NCT07093437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2025-12-10

No results posted yet for this study

Summary

Nowadays there are two types of urinary catheter securement devices, adhesive and elastic bands. The goal of this clinical trial is to determine which type of device-adhesive or elastic-is more effective for securing urinary catheters in critically ill patients. The study also aims to evaluate the prevention of urethral meatus injuries, patient discomfort, and the incidence of catheter-associated urinary tract infections .

The main questions the trial aims to answer are:

* Which device type better prevents injuries to the urethral meatus?
* Which device reduces discomfort for patients?
* Which device lowers the incidence of catheter-associated urinary tract infections?

Participants will:

* Use either an adhesive or an elastic device to secure their urinary catheter during their stay in critical care
* Be monitored regularly to assess any injuries, discomfort, or infections related to the catheter
* Provide feedback on their comfort and any complications experienced, if they are able to communicate

Conditions

  • Pressure Injuries
  • Pain
  • Catheter-Associated Urinary Tract Infection
  • Medical Device Site Injury

Interventions

DEVICE

GRIP-LOK FOLEY SECUREMENT DEVICE ®

* Used device: adhesive * Specific Skin protection: with non alcohol barrier film

DEVICE

CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER

The elastic wristband will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.

Sponsors & Collaborators

  • Hospital de la Santa creu i Sant Pau - Barcelona

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Neus Calpe Damians, PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-22
Primary Completion
2026-09-30
Completion
2026-10-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093437 on ClinicalTrials.gov