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

Condition(s) studied

Investigational drug(s) / intervention(s)

GRIP-LOK FOLEY SECUREMENT DEVICE ®: * Used device: adhesive * Specific Skin protection: with non alcohol barrier film

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.

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

Eligibility

Primary outcome measure(s)

• Urinary Catheter-related Meatal pressure injuries incidence — Through study completion, an average of 10 days
  Urinary Catheter-related Meatal pressure injuries are localized damage to the skin and underlying tissues around the urinary meatus resulting from continuous mechanical pressure from the catheter. This pressure can impair blood flow, leading to tissue ischemia, breakdown, and ulceration at the site where the catheter contacts the meatus.
• Urinary catheter-related pain in comunicative patients incidence — Through study completion, an average of 10 days
  Urinary catheter-related pain refers to the discomfort or pain experienced by patients as a direct consequence of the presence and use of an indwelling urinary catheter. This pain can arise from mechanical irritation of the urethral mucosa, bladder spasms, inflammation of the urinary tract, and tissue trauma during catheter insertion or prolonged use. This outcome will be measured only in patients with the ability to communicate effectively. To asses pain severity the Numeric Rating Scale (NRS) will be used. It consists of a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain. Patients will be asked to rate their current pain by choosing a number that best represents their pain level.
• Catheter associated-urinary tract infection incidence — Through study completion, an average of 10 days
  Catheter-Associated Urinary Tract Infection (CAUTI) is a type of urinary tract infection that occurs in patients who have an indwelling urinary catheter. It is caused by the introduction and colonization of microorganisms, often bacteria, along the catheter into the urinary tract.

Trial sites (1)

More Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials in Spain

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