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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Institut de Recerca Sant Pau
RECRUITING
Barcelona
Contact Information
Primary
Neus Calpe Damians, PhD
ncalpe@santpau.cat
+34 932 91 90 00
Backup
Mireia Llauradó Serra, PhD
mireia.llaurado@ub.edu
+34665033050
Time Frame
Start Date: 2025-09-22
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 188
Treatments
Experimental: Urinary catheter securement with adhesive device
* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be chosen with the patient's leg bent, to ensure that the securement allows for future leg movement without causing tension or pulling on the catheter.~* Catheter anchoring method: In female patients, the catheter will be anchored at the Y junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.~* Skin protection: Before applying the adhesive, a protective barrier spray (Cavilon® spray, 3M) will be applied to the selected skin area to prevent potential skin injury~* Application: The device will be applied following the manufacturer's instructions.~* Replacement: The device will be changed every 72 hours or sooner if needed. The thigh used for securement will be alterned at every change.
Experimental: Urinary catheter securement with elastic device
* Site of catheter securement: The urinary catheter will be secured on the anterior aspect of the thigh. The exact placement site will be selected with the patient's leg bent, to ensure that the securement allows for subsequent leg movement without causing pulling or tension on the catheter.~* Catheter anchoring method: In female patients, the catheter will be anchored at the Y junction of the urinary catheter. In male patients, since the external portion of the catheter is shorter, the anchoring will be done just after the sampling port of the urine collection system.~* Skin protection: The elastic band will be adjusted appropriately to minimize catheter movement while allowing normal blood circulation in the limb.~* Application: The device will be applied following the manufacturer's instructions.~* Replacement:The device will be changed every 72 hours, or sooner if necessary. The thigh used for securement will be alternated at every change
Related Therapeutic Areas
Sponsors
Collaborators: Hospital de la Santa creu i Sant Pau - Barcelona
Leads: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

This content was sourced from clinicaltrials.gov