What is the mechanism of action of this treatment?

The most common treatments for biofilm formation include the use of materials that resist bacterial adhesion, such as silicone, and the application of antimicrobial agents. Silicone catheters, like the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, reduce biofilm formation by providing a smooth surface that minimizes bacterial attachment and colonization. This is crucial for patients because biofilms can lead to persistent infections and complications, especially in long-term catheter use. Antimicrobial coatings or irrigations further inhibit bacterial growth and biofilm development, enhancing the effectiveness of the silicone material. These strategies are essential for preventing infections and improving patient outcomes.

What side effects are associated with this type of intervention?

Common treatments for biofilm formation on urinary catheters include the use of antimicrobial coatings, antibiotic-impregnated catheters, and silicone-based materials. Antimicrobial coatings and antibiotic-impregnated catheters can lead to side effects such as local irritation, allergic reactions, and the development of antibiotic-resistant bacteria. Silicone-based catheters, like the Silq ClearTract™, are generally well-tolerated but may still cause discomfort, urethral irritation, or infection if not properly managed. Overall, silicone materials are preferred for their biocompatibility and lower risk of adverse reactions compared to antimicrobial treatments.

What prior FDA approvals exist?

The FDA has approved various materials and coatings for medical devices to reduce biofilm formation, particularly in urinary catheters. Silicone, like that used in the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, is one such material known for its biocompatibility and reduced biofilm formation. Additionally, antimicrobial coatings such as silver alloy and nitrofurazone have been approved for use in urinary catheters to prevent biofilm-related infections. These treatments aim to minimize the risk of catheter-associated urinary tract infections (CAUTIs) by inhibiting bacterial colonization and biofilm development on the catheter surface.

What other types of research exist?

Promising alternatives to the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter for reducing biofilm formation include: 1) Antimicrobial-coated catheters, which use coatings such as silver alloy or antibiotics to prevent bacterial colonization. 2) Hydrophilic-coated catheters, which reduce friction and bacterial adherence. 3) Catheters with novel surface modifications, such as micro-patterned or textured surfaces, designed to disrupt biofilm formation. These innovations are being actively researched and show potential for improved outcomes in biofilm management.

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Device

Randomized Study of Silq Urinary Catheter

N/A

Waitlist Available

Research Sponsored by Hydrophilix

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Requiring indwelling 16Fr Foley catheter for at least 7 days

Male or female age ≥ 18 years old;

Must not have

Any other infection being treated with antibiotics at the time of catheter implantation

Females who are pregnant or breastfeeding or who plan to become pregnant during the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 to 7 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special silicone urinary catheter to see if it reduces bacterial buildup in patients who need catheters for extended periods. The goal is to prevent infections and other complications.

Who is the study for?

Adults aged 18 or older who need a long-term Foley catheter (16Fr size) for at least 7 days can join. They must be able to follow the study's procedures and give informed consent. People with allergies to catheter materials, urethral strictures, current UTI or other infections treated with antibiotics, needing bladder irrigation during the study, pregnant or breastfeeding women, and those in another trial cannot participate.

What is being tested?

The trial is testing if the Silq ClearTract™ Silicone Foley Catheter is better at preventing biofilm formation compared to standard urinary catheters in patients requiring long-term use. Participants will be randomly assigned to receive either the Silq catheter or a commercial one.

What are the potential side effects?

Potential side effects may include discomfort during insertion or wear of the catheter, allergic reactions if sensitive to silicone or other materials used in the device, urinary tract infection symptoms like burning sensation and foul-smelling urine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a specific catheter in place for at least a week.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on antibiotics for an infection during my catheter placement.

Select...

I am not pregnant, breastfeeding, nor planning to become pregnant during the study.

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I am currently being treated for a UTI with symptoms like fever or burning sensation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 to 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 to 7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 to 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biofilm formation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Silq ClearTract™ 100% Silicone 2-Way Foley CatheterActive Control1 Intervention

Up to 82 subjects

Group II: Silicone-coated Latex 2-Way Foley catheterActive Control1 Intervention

Up to 82 subjects

Group III: Silver-coated Latex 2-Way Foley CatheterActive Control1 Intervention

Up to 82 subjects

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for biofilm formation include the use of materials that resist bacterial adhesion, such as silicone, and the application of antimicrobial agents. Silicone catheters, like the Silq ClearTract™ 100% Silicone 2-Way Foley Catheter, reduce biofilm formation by providing a smooth surface that minimizes bacterial attachment and colonization. This is crucial for patients because biofilms can lead to persistent infections and complications, especially in long-term catheter use. Antimicrobial coatings or irrigations further inhibit bacterial growth and biofilm development, enhancing the effectiveness of the silicone material. These strategies are essential for preventing infections and improving patient outcomes.