Trial Summary
What is the purpose of this trial?This is a single arm, interventional pilot study of using chlorhexidine irrigation intra-operatively and post-operatively among patients undergoing radical cystectomy with urinary diversion. The intervention comprises of using irrigation of ileal conduit or ileal neobladder intra-operatively and then for irrigation of either post-surgery with Irrisept ®. The sterilization of urine will be assessed at 10 days after cystectomy. Incidence of symptomatic urinary tract infections within the 30-day post-operative period will be estimated.
Is the drug Chlorhexidine a promising treatment for bladder cancer?Chlorhexidine shows promise in reducing urinary infections after bladder surgeries, as it significantly lowers the rate of infections compared to not using it. However, it does not eliminate existing infections and is not recommended for long-term use due to potential bladder irritation.12567
What safety data exists for chlorhexidine irrigation in bladder cancer treatment?Chlorhexidine irrigation has been studied for its safety in bladder procedures. One study reported no toxic side effects or bladder damage from chlorhexidine irrigation, although small amounts were found in the blood of some patients. However, there is a case of anaphylaxis from intraurethral chlorhexidine in a patient with previous uneventful exposures, indicating potential sensitization. Overall, while chlorhexidine irrigation appears generally safe, there is a risk of allergic reactions.458910
What data supports the idea that Chlorhexidine Irrigation for Bladder Cancer is an effective treatment?The available research does not provide specific data supporting the effectiveness of Chlorhexidine Irrigation for Bladder Cancer. Instead, it mentions the use of Chlorhexidine for preventing infections after prostate surgery, but it was not very effective in making urine sterile. In contrast, other treatments like BCG for bladder cancer showed a much lower recurrence rate compared to Mitomycin-C and Thiotepa, suggesting BCG is more effective for preventing bladder tumor recurrence.3691112
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.
Eligibility Criteria
This trial is for patients undergoing radical cystectomy with urinary diversion due to bladder cancer. Participants must be suitable for surgery and willing to have their surgical site irrigated with a chlorhexidine solution both during and after the procedure.Inclusion Criteria
I have been diagnosed with bladder cancer.
I am a candidate for major bladder surgery with a new way for urine to exit my body.
I can take care of myself and am up and about more than half of the day.
Exclusion Criteria
I have had or will have surgery to redirect urine flow not using ileal conduit or neobladder.
Treatment Details
The study tests the effectiveness of Irrisept® (a chlorhexidine-based antimicrobial wound lavage) in sterilizing urine and reducing urinary tract infections when used during and after bladder surgery.
1Treatment groups
Experimental Treatment
Group I: Patients undergoing radical cystectomy with urinary diversionExperimental Treatment1 Intervention
Patients undergoing radical cystectomy and ileal conduit or ileal neobladder will receive Irrisept ® Antimicrobial Wound Lavage as intervention
Chlorhexidine is already approved in European Union, United States, Canada, Japan, Australia for the following indications:
🇪🇺 Approved in European Union as Chlorhexidine for:
- Preoperative skin preparation
- Hand hygiene
- Mouthwash
- Dental plaque control
- Gingivitis treatment
- Skin infections
- Wound care
🇺🇸 Approved in United States as Chlorhexidine for:
- Preoperative skin preparation
- Hand hygiene
- Mouthwash
- Dental plaque control
- Gingivitis treatment
- Skin infections
- Wound care
🇨🇦 Approved in Canada as Chlorhexidine for:
- Preoperative skin preparation
- Hand hygiene
- Mouthwash
- Dental plaque control
- Gingivitis treatment
- Skin infections
- Wound care
🇯🇵 Approved in Japan as Chlorhexidine for:
- Preoperative skin preparation
- Hand hygiene
- Mouthwash
- Dental plaque control
- Gingivitis treatment
- Skin infections
- Wound care
🇦🇺 Approved in Australia as Chlorhexidine for:
- Preoperative skin preparation
- Hand hygiene
- Mouthwash
- Dental plaque control
- Gingivitis treatment
- Skin infections
- Wound care
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mount Sinai HospitalNew York, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
Irrimax CorporationIndustry Sponsor
References
Hibitane bladder irrigation in the prevention of catheter-associated urinary infection. [2019]The effect of regular chlorhexidine bladder irrigations on catheter-induced urinary infection in patients admitted as urological emergencies was investigated. Excluding patients infected on admission the urine remained sterile throughout the period of catheterisation in 52% of those receiving chlorhexidine but in only 26% of a control group of patients.
The effect of chlorhexidine irrigation of the bladder in the rat. [2019]Rats' bladders were irrigated with aqueous solutions of chlorhexidine digluconate 1 : 5,000 or 1 : 10,000 for varying periods up to 48 hours. Histologic examination of the bladders showed severe erosive cystitis in a high percentage of cases. It is concluded that chlorhexidine cannot be recommended for prolonged irrigation of the bladder or for instillation during the intermittent catheterisation where chlorhexidine has repeated and prolonged contact with bladder mucosa.
[Intravesical BCG, mitomycin-C and thiotepa in the prevention of bladder tumor recurrence after operation]. [2013]We observed the effects of intravesical irrigation with BCG (group B), Mitomycin-C (group M), and Thiotepa (group T) in prophylaxis of bladder tumor recurrence after surgical treatment. Follow-up for 1-10 years showed that the recurrence rate of bladder tumor was 12.5% (3/24) in group B, 46.9% (15/33) in group M, and 61.8% (21/34) in group T respectively. The effect of BCG was far better than that Mitomycin-C and Thiotepa (P
A comparison of the effect of chlorhexidine antisepsis, soap and antibiotics on bacteriuria, perineal colonization and environmental contamination in spinally injured patients. [2019]The effect of chlorhexidine antisepsis on bacteriuria, perineal colonization by coliforms and environmental contamination by these organisms was investigated in spinally injured patients treated by intermittent catheterization. Patients were body washed daily in chlorhexidine and chlorhexidine cream was applied to the glans penis after each catheterization. Urine cultures were obtained each day. A statistically significant reduction in bacteriuria was achieved by antisepsis in male patients not receiving antibiotics, from 74% of urine cultures in patients receiving soap to 60% with antisepsis (P less than 0.01). No effect of antisepsis was found on perineal coliform colonization, nor on contamination of bed sheets or the environment by these organisms. There was a significant reduction in perineal coliforms by antibiotics.
Bladder irrigation with chlorhexidine for the prevention of urinary infection after transurethral operations: a prospective controlled study. [2019]The value of postoperative bladder irrigation with the antiseptic agent chlorhexidine was assessed in a randomized prospective controlled study of men after transurethral operations. In patients with sterile preoperative urine the incidence of postoperative bacteriuria was 12.8 per cent, compared to 36.7 per cent in control patients. The difference is significant (chi-square 5.54, p less than 0.02). On the other hand, chlorhexidine irrigation did not eliminate pre-existing infection. Small amounts of chlorhexidine were demonstrated in the blood of some patients. There was no evidence of damage to the bladder and no toxic side effects.
The use of intermittent chlorhexidine bladder irrigation in the prevention of post-prostatectomy infective complications. [2013]The efficacy of peri-operative intermittent bladder irrigation with 0.05% chlorhexidine gluconate solution in the prevention of post-prostatectomy infective complications was assessed in men with pre-operative indwelling urinary catheters. Thirty-two consecutive patients undergoing transvesical prostatectomy were randomly allocated to the test group (chlorhexidine irrigation) and control group (saline irrigation). Pre-operatively, intermittent chlorhexidine bladder irrigation achieved sterile urine in only 3 of 13 patients, in the rest bacteriuria persisted. However, the irrigation was able to reduce significantly (P
Water versus antiseptic periurethral cleansing before catheterization among home care patients: a randomized controlled trial. [2013]There is a lack of research studies on periurethral cleansing before catheterization among home care patients. The purpose of this study was to compare the risk of acquiring symptomatic urinary tract infections through the conventional practice of using 0.05% chlorhexidine gluconate (CHG) versus sterile water for periurethral cleansing before insertion of an indwelling urinary catheter.
Anaphylactic reaction to intraurethral chlorhexidine: sensitisation following previous repeated uneventful administration. [2021]Instillagel(®) (CliniMed, High Wycombe, UK) is commonly used in urethral catheterisation and to facilitate the passage of instruments into the bladder in urological practice. Its active ingredients include 0.25% chlorhexidine, 2% lidocaine, 0.06% methyl hydroxybenzoate and 0.025% propyl hydroxybenzoate. We discuss the case of an 84-year-old man who received intraurethral Instillagel(®) prior to laser ablation of a recurrent transitional cell carcinoma of the bladder, resulting in anaphylaxis. Subsequent investigation confirmed allergy to chlorhexidine. Although there are previous reports in the literature, this is the first report of intraurethral chlorhexidine resulting in anaphylaxis in a patient who had had repeated, uneventful previous exposures. As such, this case illustrates the phenomenon of chlorhexidine sensitisation and that previous uneventful exposures do not exclude the diagnosis of anaphylaxis in the context of sudden, unexpected deterioration.
Randomized controlled study of the efficacy and safety of continuous saline bladder irrigation after transurethral resection for the treatment of non-muscle-invasive bladder cancer. [2017]To evaluate the efficacy and safety of continuous saline bladder irrigation (CSBI) after transurethral resection of bladder tumour (TURBT) in patients with low- to intermediate-risk non-muscle invasive bladder cancer (NMIBC).
[Low-concentration hydrogen peroxide solution for continuous bladder irrigation after transurethral resection of the prostate]. [2022]To evaluate the effectiveness and safety of low-concentration hydrogen peroxide solution (HPS) for continuous bladder irrigation after transurethral resection of the prostate (TURP).
Continuous saline bladder irrigation after blue light transurethral resection of bladder tumor increases recurrence-free survival in low- to intermediate-risk non-muscle invasive bladder cancer. [2021]To evaluate the efficacy of Continuous Saline Bladder Irrigation (CSBI) after blue light transurethral resection of bladder tumor (TURBT) to prevent recurrence of low- to intermediate-risk Non-Muscle Invasive Bladder Cancer (NMIBC).
Overnight Continuous Saline Bladder Irrigation After En Bloc Resection of Bladder Tumor Does Not Improve Oncological Outcomes in Patients Who Have Received Intravesical Chemotherapy. [2022]Label="OBJECTIVE" NlmCategory="OBJECTIVE">To evaluate the safety and efficacy of overnight continuous saline bladder irrigation (CSBI) for patients who have received thulium laser en bloc resection of bladder tumor (TmLRBT) combined with immediate intravesical chemotherapy previously.