Clinical Evaluation of Copesilcup

NCT07530328 | Completed DMC

• 2 other identifiers: 001IT21I0048
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Healthcare-associated infections (HAIs): HAIs are a problem for all institutions and countries worldwide. Currently, one of the main infections is catheter-associated urinary tract infection (CAUTI). Problem: Infection associated with permanent urinary catheters is a problem with a significant social and public health impact due to its high morbidity, mortality, and associated costs. The COPESIL technology developed in the FONDEF ID19I10113 project consists of the modification and functionalization of silicone materials through the anchoring of polyethylene glycol molecules on their surface (pegylation process). Our technology showed significant antimicrobial and anti-biofilm capacity in in vitro and in vivo models. This proposal aims to scale up COPESIL technology to a permanent urinary catheter that we have named COPESILCUP. The creation of a new device and its clinical validation will open up and revolutionize research in biomaterials. State of the art: Currently, there are a variety of urinary catheters designed to reduce the risk of infection. These include catheters impregnated with antibiotics (nitrofurantoin, minocycline, and rifampicin), silver oxide, and silver alloys. However, these catheters have little effect on the adhesion of uropathogens. The hypothesis is proposed: The use of a permanent silicone urinary catheter modified through a pegylation process that incorporates copper nanoparticles (COPESILCUP), which has antimicrobial and anti-biofilm properties, reduces the incidence of urinary tract infection in hospitalized adults who use permanent urinary catheters compared to unmodified silicone urinary catheters. The overall objective of this project is to develop a permanent silicone urinary catheter modified through a pegylation process that incorporates copper nanoparticles (COPESILCUP), which has antimicrobial and anti-biofilm properties, and to evaluate its efficacy by measuring the incidence of urinary tract infections and its safety in humans using permanent urinary catheters in a public hospital for adults. Methodology: Clinical validation of COPESILCUP in a Randomized Controlled Clinical Trial: the aim is to validate the medical device in a real patient setting in order to establish whether it is better than the standard.

Conditions

Catheter-Associated Infection

Keywords

Catheter-Associated Urinary Tract Infection; Urinary Tract Infection; Healthcare-Associated Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of Catheter-Associated Urinary Tract Infection (CAUTI)

  Incidence of catheter-associated urinary tract infection, defined as the presence of a positive urine culture combined with clinical and/or laboratory findings consistent with urinary tract infection, assessed during the period of permanent urinary catheter use.

  At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days) of follow-up or until catheter removal, whichever occurs first

Secondary Outcomes (3)

• Time to First Positive Urine Culture

  At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days).

• Relative Risk of Catheter-Associated Urinary Tract Infection

  At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days).

• Incidence of Device-Related Adverse Events

  From Day 1 (catheter insertion) up to 30 days or until catheter removal, whichever occurs first

Other Outcomes (1)

• Microbiological Profile of Uropathogens

  At Day 1 (baseline), Day 7, Day 14, Day 21, and Day 28 (up to 30 days).

Study Arms (2)

COPESILCUP Urinary Catheter

EXPERIMENTAL

Participants assigned to this group receive an indwelling urinary catheter made of medical-grade silicone with surface modification incorporating copper-based nanoparticles (COPESILCUP). The catheter is inserted and managed according to standard clinical practice for urinary catheterization.

Device: PEGylated Silicone Urinary Catheter with Copper Nanoparticles (COPESILCUP)

Standard Silicone Urinary Catheter

OTHER

Participants assigned to this group receive a standard indwelling urinary catheter made of medical-grade silicone without surface modification. The catheter is inserted and managed according to routine clinical practice.

Device: Control Device

Interventions

Control Device DEVICE

The control intervention consists of the use of a standard permanent urinary catheter made of medical-grade silicone without surface modification. The catheter is inserted following standard sterile clinical procedures for permanent urinary catheterization and managed according to routine hospital care protocols. Catheter insertion, fixation, maintenance, and removal are performed by trained nursing staff using a closed urinary drainage system. Urine samples are collected at baseline, during catheter use according to institutional protocols, and at catheter removal for urinalysis and urine culture. Participants are monitored during catheter use for the occurrence of catheter-associated urinary tract infection and for device-related adverse events. No additional procedures beyond standard clinical care for permanent urinary catheter use are required.

Standard Silicone Urinary Catheter

PEGylated Silicone Urinary Catheter with Copper Nanoparticles (COPESILCUP) DEVICE

The intervention consists of the use of a permanent urinary catheter made of medical-grade silicone modified through a PEGylation process incorporating copper nanoparticles (COPESILCUP). The investigational catheter is inserted following standard sterile clinical procedures for permanent urinary catheterization, in accordance with institutional infection prevention protocols. Catheter insertion, fixation, maintenance, and removal are performed by trained nursing staff using a closed urinary drainage system. Urine samples are collected at the time of catheter insertion (baseline), every 7 days during catheterization, and at catheter removal for urinalysis and urine culture. Participants are monitored throughout catheter use for the occurrence of catheter-associated urinary tract infection and for device-related adverse events. No additional procedures beyond standard clinical care for permanent urinary catheter use are required. The intervention differs from standard care only in the

Also known as: PEGylated Silicone Urinary Catheter with Copper Nanoparticles, COPESIL Modified Urinary Catheter, COPESILCUP

COPESILCUP Urinary Catheter

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years of age).
• Hospitalized patients from medical, surgical, emergency, operating room, or intensive care units.
• Patients with clinical indication for permanent urinary catheterization (Catéter Urinario Permanente, CUP).
• Patients able to provide written informed consent, or consent provided by a legally authorized representative.

You may not qualify if:

• History of urinary tract infection prior to hospitalization within the last month without a post-treatment follow-up urine culture.
• Patients with a positive initial urine culture at the time of permanent urinary catheter (CUP) insertion.
• Patients with a history of allergy to silicone or to any component of the COPESILCUP device.
• Patients unable to complete follow-up, for example, due to transfer to another healthcare facility within the first 72 hours after stabilization.
• Patients with psychiatric conditions that may result in non-professional manipulation of the urinary catheter.
• Patients with a history of prior urinary tract colonization.
• Patients with a history of urinary or renal instrumentation or surgical intervention within the last month.
• Patients with pre-existing abnormalities of the pyeloureteral or urinary system.

Sponsors & Collaborators

• WMAS SpA: lead
• Hospital del Salvador: collaborator
• Universidad Bernardo O'Higgins: collaborator
• Instituto Nacional de Neurología y Neurocirugía: collaborator
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

WMAS SpA

Ñuñoa, Santiago Metropolitan, 750000, Chile

Location

MeSH Terms

Conditions

Catheter-Related Infections; Urinary Tract Infections; Cross Infection

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking Description This study is triple-blinded. Study participants, healthcare providers responsible for catheter insertion and clinical care, and outcome assessors are blinded to treatment allocation. The investigational device (COPESILCUP) and the control device (standard silicone urinary catheter) are visually indistinguishable and are packaged and labeled using coded identifiers. Randomization codes are generated and maintained by personnel not involved in patient care, outcome assessment, or data analysis. Blinding is maintained throughout the study period until completion of data collection and primary analyses. Unblinding is permitted only in the event of a serious adverse event when knowledge of the assigned device is necessary for patient safety.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Public Health

Model Details: This study is a multicenter, randomized, triple-blind, controlled clinical trial with a parallel-group design. Hospitalized adult patients requiring permanent urinary catheterization are enrolled and randomly assigned in a 1:1 ratio to one of two study arms: the intervention group receives a PEGylated silicone permanent urinary catheter incorporating copper nanoparticles (COPESILCUP), and the control group receives a standard medical-grade silicone permanent urinary catheter without surface modification. Randomization is performed using block randomization to ensure balanced allocation between groups. Allocation concealment is maintained throughout the study. The trial is triple-blinded: participants, healthcare providers responsible for catheter insertion and care, and outcome assessors are unaware of group assignment. The primary purpose of the study is prevention of catheter-associated urinary tract infection. Participants are followed prospectively from the time of catheter inse

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: April 15, 2026
• Study Start: January 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)