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Recruiting NCT07093437

NCT07093437 Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study

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Clinical Trial Summary
NCT ID NCT07093437
Status Recruiting
Phase
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Condition Pressure Injuries
Study Type INTERVENTIONAL
Enrollment 188 participants
Start Date 2025-09-22
Primary Completion 2026-09-30

Trial Parameters

Condition Pressure Injuries
Sponsor Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study Type INTERVENTIONAL
Phase N/A
Enrollment 188
Sex ALL
Min Age 18 Years
Max Age 99 Years
Start Date 2025-09-22
Completion 2026-09-30
Interventions
GRIP-LOK FOLEY SECUREMENT DEVICE ®CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER

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Brief 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 Criteria

Inclusion Criteria: * 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 Criteria: * 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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