Irrisept for Urinary Tract Infection

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Breastfeeding, Infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Immediate

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to prevent urinary tract infections (UTIs) after catheter removal without antibiotics. It compares Irrisept, an antiseptic solution, to standard saline irrigation to determine if it reduces infection rates. The goal is to find a better way to prevent UTIs and potentially change future catheter removal practices. The trial seeks participants visiting the urology clinic for catheter removal who are willing to complete a survey afterward. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future catheter removal procedures.

What prior data suggests that Irrisept is safe for urinary tract infection prevention?

Research has shown that Irrisept is safe to use. Studies have found it non-toxic and well-tolerated in both lab tests and real-life situations. It contains a small amount of Chlorhexidine Gluconate, which is safe for short-term use on damaged skin or tissue. Extensive testing, including lab and clinical studies, has confirmed its safety. This makes it a promising option for reducing urinary tract infections without antibiotics. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Irrisept for treating urinary tract infections because it offers a unique approach compared to traditional antibiotics. While most treatments for UTIs rely on antibiotics to kill bacteria, Irrisept works by cleansing the urinary tract using an antiseptic irrigation solution. This method might reduce the risk of antibiotic resistance, a growing concern with standard UTI treatments. Additionally, Irrisept's local application directly targets the infection site, potentially leading to quicker relief from symptoms.

What evidence suggests that Irrisept is effective for preventing UTIs?

Studies have shown that Irrisept, containing a small amount of chlorhexidine gluconate (0.05%), can effectively reduce infections. Research indicates that this solution lowers the risk of infections by about 50% compared to other methods. This antiseptic kills bacteria that cause infections, offering a promising option without relying on antibiotics. Previous studies demonstrated that using Irrisept to rinse the bladder reduced urinary tract infections in some patients, especially those undergoing certain medical procedures. In this trial, participants will receive either Irrisept or standard care in separate treatment arms. Overall, Irrisept has a strong track record of safety and effectiveness in preventing infections. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for patients at risk of urinary tract infections (UTIs) after having a urethral catheter removed. The study seeks participants who are likely to benefit from non-antibiotic interventions to prevent UTIs.

Inclusion Criteria

Must be willing to complete a post-catheter removal survey

I am going to the urology clinic to have my catheter removed.

I understand the study and agree to participate.

Exclusion Criteria

Allergy or adverse reaction to chlorohexidine gluconate

I have signs of an infection on my skin or in my body.

I am scheduled for a catheter exchange.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Irrisept or saline irrigation during urethral catheter removal

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for urinary tract infections and adverse events after catheter removal

4 weeks

1 visit (in-person), additional monitoring as needed

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept

Trial Overview The trial is testing the effectiveness of Irrisept, which contains 0.05% Chlorhexidine Gluconate, against normal saline in preventing UTIs post-catheter removal. It aims to establish if antiseptic bladder irrigation can be a standard practice.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 1 Intervention

Experimental

Group II: Control Active Control 1 Intervention

Standard of care

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Irrimax Corporation

Industry Sponsor

Trials

11

Recruited

2,100+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07239219

The Impact of Irrisept in Reducing Urinary Tract Infection ... By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11491223/

Comparing 0.05% chlorhexidine gluconate monotherapy to ... Surgical and manufacturer efforts managed to reduce the risk of PP infection by about 50%.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772973725007611

Catheter surface technology meets antimicrobial activation ... In-vitro microbiological studies compared outcomes of catheter activation with 0.05% CHG wash solution (Irrisept™) and 0.05% CHG lube (Endosgel™) vs sterile ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06347

Chlorhexidine Irrigation to Reduce Urinary Tract Infections ... Bladder irrigation with using Irrisept may reduce the rate of urinary tract infections in patients with bladder cancer undergoing radical cystectomy with ...

5. irrisept.com irrisept.com/research/

Research Irrisept features an extensive safety profile with in-vitro and in-vivo studies and RCT data, with >12 years of proven history and testing.

6. imgcdn.mckesson.com imgcdn.mckesson.com/CumulusWeb/Click_and_learn/MSDS_IRAMAX_MAX302_MAX304_IRRISEPT_PRODUCT_LINE.pdf

MSDS - IrriSept - Chlorhexidine Gluconate The attached Material Safety Data Sheet (MSDS) is for all IrriSept products containing Chlorhexidine Gluconate (0.05%) in Water for.

7. irrisept.com irrisept.com/products/

Products Irrisept solution meets biocompatibility guidelines for ≤ 24 hours contact with breached or compromised surfaces (ISO 10993-1).

8. irrisept.com irrisept.com/

Irrisept: Home An extensive safety profile including in-vivo and in-vitro studies and RCT data. ... Irrisept is non-cytotoxic and features extensive safety testing ...

9. irrisept.com irrisept.com/wp-content/uploads/2024/08/Irrisept-Brochure-772722-V5.pdf

DO YOUR BEST AGAINST THE WORST. Irrisept's evidence includes in-vivo and in-vitro testing as well as RCT safety data. 4-6 Reports for testing are available upon request. ...