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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • GRIP-LOK FOLEY SECUREMENT DEVICE ®

    Device

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

  • CONVEEN, ELASTIC LEG WRISTBAND FOR URINARY CATHETER

    Device

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

Treatment groups

188 Participants
are divided into 2 treatment groups
Group A: Urinary catheter securement with adhesive deviceExperimental treatment 1 intervention
Group B: Urinary catheter securement with elastic deviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Urinary Catheter-related Meatal pressure injuries incidence

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.

Time frame
Through study completion, an average of 10 days
2

Urinary catheter-related pain in comunicative patients incidence

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.

Time frame
Through study completion, an average of 10 days
3

Catheter associated-urinary tract infection incidence

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.

Time frame
Through study completion, an average of 10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator