RecruitingNot ApplicableNCT07093437

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

Dispositivos Adhesivos Frente a Dispositivos elásticos Para la sujeción de la Sonda Urinaria en el Paciente crítico Estudio Experimental


Sponsor

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

Enrollment

188 participants

Start Date

Sep 22, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • Age > 18 years
  • Pacients with an urinary catheter inserted within the past 24 hours
  • Expected duration of catheterization >48 hours
  • Estimated ICU lenght os stay > 48 hours

Exclusion Criteria4

  • Known allergy to adhesive tape
  • Patients with lesions at the urinary meatus, ongoing urinary tract infection or suspected infection
  • Presence of urological or prostatic pathology
  • Any condition that prevents securing the urinary catheter to the thigh, such as wounds, burns, or amputations

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Interventions

DEVICEGRIP-LOK FOLEY SECUREMENT DEVICE ®

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

DEVICECONVEEN, 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.


Locations(1)

Institut de Recerca Sant Pau

Barcelona, Spain

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NCT07093437


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