Catheter-associated meatal pressure injury in hospitalized males.
Chen Shenhar, Marina Mansvetov, Jack Baniel...
https://pubmed.ncbi.nlm.nih.gov/32339318Actively Recruiting
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-12-10
188
Participants Needed
1
Research Sites
4 weeks
Total Duration
F
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead Sponsor
H
Hospital de la Santa creu i Sant Pau - Barcelona
Collaborating Sponsor
Researchers are evaluating two types of devices used to secure urinary catheters in critically ill patients: adhesive devices and elastic wristband-style devices. The study aims to determine which device is more effective at preventing injuries to the urethral meatus, reducing patient discomfort, and lowering the rate of catheter-associated urinary tract infections. This is an experimental, randomized trial conducted in an Intensive Care Unit setting, addressing a significant gap in clinical guidelines and nursing practices regarding catheter securement methods. Participants will be randomly assigned to use either a commercially available adhesive device or an elastic wristband device to secure their urinary catheter on the front of the thigh. The placement is carefully chosen to allow leg movement without tension on the catheter. For adhesive devices, a protective barrier spray is applied before use, while elastic bands are adjusted to minimize movement and maintain circulation. Devices will be replaced every 72 hours or earlier if needed, alternating the thigh used for securement at each change. During the study, participants will be regularly monitored for catheter-related complications such as meatal injuries, discomfort or pain (if the patient can communicate), and urinary tract infections. Researchers will collect feedback from communicative patients about their comfort and any issues experienced. The primary outcomes are measured over an average period of 10 days. This monitoring includes clinical assessments and tracking any adverse events like catheter obstruction, skin lesions, or accidental catheter dislodgement.
CONDITIONS
Adhesive Devices Versus Elastic Devices for Urinary Catheter Securement in Critically Ill Patients Experimental Study
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants receive urinary catheter securement using either adhesive or elastic wristband devices applied to the thigh to prevent catheter-associated complications.
Device replaced every 72 hours or sooner if needed with alternating thigh site
Total: 1 location
1
Institut de Recerca Sant Pau
Barcelona, Spain, 08024
Actively Recruiting
N
Neus Calpe Damians, PhD
M
Mireia Llauradó Serra, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Chen Shenhar, Marina Mansvetov, Jack Baniel...
https://pubmed.ncbi.nlm.nih.gov/32339318Eun Bi Jang, Seong Hwi Hong, Kyu Shik Kim...
https://pubmed.ncbi.nlm.nih.gov/33401353Neus Calpe-Damians, Laia Wennberg-Capellades, Arminda Ventura-Rosado...
https://pubmed.ncbi.nlm.nih.gov/38955490Sharon Holroyd
https://pubmed.ncbi.nlm.nih.gov/31393768Neus Calpe-Damians, Mireia Llaurado-Serra, Laia Wennberg-Capellades
https://pubmed.ncbi.nlm.nih.gov/37977003