Irrisept vs Antibiotics for Penile Prosthesis Placement

Not currently recruiting at 1 trial location

Overseen By Laurence Levine, MD

Age: Any Age

Sex: Male

Trial Phase: Phase 3

Sponsor: Rush University Medical Center

Disqualifiers: Revision surgeries, Complex reconstruction, Transgender males

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Irrisept, an antimicrobial wound lavage, is as effective as traditional antibiotics for cleaning during penile implant surgery. The focus is on preventing infections when placing a first-time inflatable penile prosthesis. Two groups participate: one uses traditional antibiotics, and the other uses only Irrisept during the procedure. Men undergoing their first penile implant surgery, without complex reconstruction, are suitable candidates for this trial. Researchers will monitor participants for infections or complications for one year after surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential approval of a new treatment option.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Irrisept, a germ-fighting wash, is safe to use. It has undergone testing in both labs and real-life situations. These studies found that Irrisept is safe and easy for people to tolerate. It cleans wounds and surgical areas to help prevent infections.

One study discovered that Irrisept can reduce the number of harmful bacteria that might cause infections after surgery. This is especially important for patients receiving a penile prosthesis, an inflatable device that helps with erectile dysfunction. The study showed that Irrisept works as effectively as using multiple antibiotics for this purpose.

Overall, evidence suggests that Irrisept is safe for use in surgeries. It has been tested in different settings and remains effective in preventing infections without causing major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard antibiotic regimen used during penile prosthesis placement, Irrisept offers a unique approach by utilizing a chlorhexidine-based irrigation solution. This treatment is distinctive because it targets bacteria through a powerful antiseptic mechanism rather than relying on traditional antibiotics like rifampin or gentamycin. Researchers are excited about Irrisept as it may reduce reliance on antibiotics, potentially lowering the risk of antibiotic resistance and providing a more straightforward, single-step infection control method during surgery.

What evidence suggests that this trial's treatments could be effective for penile prosthesis placement?

Research has shown that Irrisept, which contains the germ-killing ingredient chlorhexidine gluconate, effectively combats bacteria that can cause infections after penile implant surgery. In lab tests, Irrisept has fought off both aerobic and anaerobic bacteria, as well as fungi, which often cause surgical infections. This trial will compare the effectiveness of Irrisept, used in one treatment arm, to traditional antibiotic irrigation, used in another arm, during penile prosthesis placement surgeries. Although direct data comparing Irrisept to antibiotics for this specific surgery is limited, earlier findings suggest it could be a strong alternative. ^{1 2 3 4 6}

Who Is on the Research Team?

Edward Cherullo, MD

Principal Investigator

Rush University

Laurence Levine, MD

Principal Investigator

Rush University

Are You a Good Fit for This Trial?

This trial is for men getting their first penile prosthesis implant, regardless of the brand. It's not for those needing complex surgery like grafts for Peyronie's Disease, men having revision surgeries, or transgender males.

Inclusion Criteria

I am getting a penile prosthesis implant.

Exclusion Criteria

I may need surgery with special reconstruction for Peyronie's Disease.

I am a man scheduled for a revision implant surgery.

I am a transgender male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo penile prosthesis surgery with either Irrisept or traditional antibiotic irrigation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for penile prosthesis infection and surgical complications

1 year

Regular intervals for 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Irrisept
• Traditional Antibiotic Irrigation

Trial Overview The study is testing if Irrisept irrigation during surgery is as good as using multiple antibiotics (Gentamicin, Rifampin, Chlorhexidine) to prevent infection in new inflatable penile prosthesis devices.

How Is the Trial Designed?

Group I: Irrisept only irrigation Experimental Treatment 1 Intervention

Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with Irrisept only immediately after the space is created in all cases. An additional scrotal irrigation with Irrisept only after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.

Group II: Traditional Antibiotic Therapy Active Control 2 Interventions

Preoperative antibiotic selection, method or preparation, draping, or technique;. the corpora, scrotum, and reservoir space will be irrigated with traditional antibiotics (rifampin, gentamycin, +/-fluconazole) immediately after the space is created in all cases. An additional scrotal irrigation with traditional antibiotics after all components are placed will be performed, as well. The patients will be followed and monitored for penile prosthesis infection as well as any other surgical complications for 1 year post operatively.

Irrisept is already approved in United States for the following indications:

Approved in United States as Irrisept for:

• Mechanical cleansing and removal of debris, dirt, and foreign materials, including microorganisms from wounds

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

In a study of 200 patients with periprosthetic joint infections treated with irrigation and debridement (I&D), the failure rate for streptococcal infections was 65%, which is comparable to the 71% failure rate for infections caused by other organisms.

The findings suggest that I&D is not particularly effective for treating PJI, regardless of the type of infecting organism, indicating that its role in treatment protocols should be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irrigation and debridement for periprosthetic infections: does the organism matter? Odum, SM., Fehring, TK., Lombardi, AV., et al.[2022]

Infection after penile prosthesis placement is rare, but if it occurs, the implant and all foreign materials must be removed, with options for future replacement or immediate salvage procedures.

In a study of 101 patients, the salvage procedure had an 84% success rate, although success is lower if the infection occurs soon after surgery, involves severe cellulitis, or is caused by aggressive bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment alternatives for the infected penile implant. Mulcahy, JJ.[2010]

In a study of 13 patients with prosthetic-joint-associated infections after total hip arthroplasty, 86% were successfully treated using irrigation and debridement with antibiotic-impregnated calcium hydroxyapatite, showing its efficacy as a novel antibiotic delivery system.

No complications were reported from the use of antibiotic-impregnated CHA, indicating a safe treatment option for managing infections in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of Irrigation and Debridement with Topical Antibiotic Delivery Using Antibiotic-Impregnated Calcium Hydroxyapatite for the Management of Periprosthetic Hip Joint Infection. Wakabayashi, H., Hasegawa, M., Naito, Y., et al.[2023]

The study found that 0.05% chlorhexidine (CHG) lavage does not damage the coating of hydrophilic inflatable penile prostheses (hIPPs) and that the adherence of this solution is consistent regardless of dip time, indicating its safety for use during surgical procedures.

This research suggests that 0.05% CHG may offer advantages over previously used antibiotic solutions for irrigation, potentially serving as a new effective option to reduce infection rates in penile prosthesis surgeries, although clinical validation is still needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of 0.05% chlorhexidine gluconate in water on the hydrophilic inflatable penile prosthesis: biocompatibility, adherence, and dip time. Griggs, R., Karpman, E., Jones, L., et al.[2023]

Two patients with prosthetic joint infections were successfully treated using a single-stage revision procedure combined with a long-acting antibiotic called oritavancin.

This approach may offer a more efficient treatment option compared to traditional methods, which often require multiple stages and prolonged antibiotic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Oritavancin (Novel New Lipoglycopeptide) in the Treatment of Prosthetic Joint Infections (PJI): A Possible Alternative Novel Approach to a Difficult Problem. Antony, SJ., Cooper, LG.[2022]

Irrigation and debridement with prosthetic retention (I&D) had a success rate of only 52% in treating periprosthetic joint infections (PJI) among 146 patients, indicating that this procedure may not be very effective overall.

The study found that 83.7% of cases that failed I&D had the same organism persist, particularly highlighting that infections caused by methicillin-resistant Staphylococcus aureus had a significantly higher risk of persistence, suggesting that I&D should be used cautiously in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrent Periprosthetic Joint Infection After Irrigation and Debridement With Component Retention Is Most Often Due to Identical Organisms. Zmistowski, BM., Manrique, J., Patel, R., et al.[2022]

In a study of 4205 men who received inflatable penile prostheses, those with InhibiZone antibiotic treatment had a significantly lower infection rate of 0.28% after 60 days compared to 1.59% in the untreated group, demonstrating an 82.4% reduction in infections.

After 180 days, the infection rate remained lower in the InhibiZone group at 0.68% versus 1.61% in the control group, indicating that the antibiotic surface treatment effectively reduces postoperative infections over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of antibiotic impregnation of inflatable penile prostheses in decreasing infection in original implants. Carson, CC.[2022]

The study presents a new technique for salvaging inflatable penile prostheses (IPP) using 0.05% chlorhexidine gluconate for irrigation, which showed no cases of infection or erosion in four patients over a median follow-up of 4.8 months.

This method allows for the maintenance of corporal length during the salvage procedure, making it a promising option for patients with prior IPP infections, as two patients opted for repeat IPP insertion after 6 months with the same cylinder size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three piece penile prosthesis salvage with chlorhexidine gluconate and length preservation: our technique and outcomes. Razdan, S., Siegal, AR., Celtik, KE., et al.[2023]

In a review of 269 patients who underwent penile prosthetic implantation over 10 years, the infection rate was low at 1.9%, attributed to strict surgical techniques and the use of perioperative antibiotics.

Six patients developed infections, all of whom had pre-existing conditions like urinary tract infections, neurogenic bladder, or diabetes, indicating that certain health issues can increase the risk of infection despite preventive measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with penile prosthesis infection. Radomski, SB., Herschorn, S.[2019]

Conservative therapy (CT) using antibiotics for early, localized penile implant (PI) infections has a high success rate, with 33 out of 37 patients retaining their implants and resuming sexual activity after treatment.

Only 4 patients (11%) required removal of the implant due to treatment failure, indicating that CT can be a viable alternative to immediate surgical removal in managing PI infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conservative Therapy is an Effective Option in Patients With Localized Infection After Penile Implant Surgery. Habous, M., Farag, M., Williamson, B., et al.[2018]

In a study of 45 patients who underwent irrigation and debridement with component retention (IDCR) for acute periprosthetic joint infections (PJIs) after aseptic revision total joint arthroplasties, 80% of implants remained free from re-revision for infection at 5 years, indicating good long-term efficacy.

The approach, combined with suppressive antibiotic therapy (SAT), shows promise as a viable treatment option for managing acute infections in revision surgeries, especially since the risk of implant removal can be significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irrigation and Debridement With Chronic Antibiotic Suppression for the Management of Acutely Infected Aseptic Revision Total Joint Arthroplasties. Salmons, HI., Bettencourt, JW., Wyles, CC., et al.[2023]

Exebacase, a lysin, was safely administered during arthroscopic debridement in four elderly patients with multidrug-resistant S. epidermidis prosthetic knee infections, showing no adverse events during the procedure.

After more than a year of follow-up, two patients showed significant clinical improvement with the disappearance of septic arthritis symptoms, suggesting that exebacase may enhance the effectiveness of suppressive antibiotics in treating these challenging infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arthroscopic "Debridement and Implant Retention" With Local Administration of Exebacase (Lysin CF-301) Followed by Suppressive Tedizolid as Salvage Therapy in Elderly Patients for Relapsing Multidrug-Resistant S. epidermidis Prosthetic Knee Infection. Ferry, T., Batailler, C., Souche, A., et al.[2021]

In a study of 117 patients with early prosthetic joint infections (PJI) managed by debridement and irrigation, antibiotics, and implant retention (DAIR), 57.3% achieved infection cure and implant salvage, indicating that DAIR can be an effective treatment strategy.

However, the study found that infections caused by methicillin-resistant S. aureus and those treated at a specific hospital had significantly higher failure rates, suggesting that these factors should be considered when evaluating treatment options for PJI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early prosthetic joint infection: outcomes with debridement and implant retention followed by antibiotic therapy. Cobo, J., Miguel, LG., Euba, G., et al.[2011]

In cases where surgical removal of an infected prosthesis is not feasible, long-term oral suppressive antibiotic therapy can maintain the function of the prosthesis in 86.2% of patients over an average follow-up of 5 years.

The study found a 69% success rate for treating Staphylococcus aureus infections in prosthetic joints, indicating that while outcomes can be favorable, further research is needed to determine the best oral antibiotic regimens and treatment durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term suppression of infection in total joint arthroplasty. Rao, N., Crossett, LS., Sinha, RK., et al.[2005]

Citations

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

Comparing 0.05% chlorhexidine gluconate monotherapy to ... The study aims to assess the non-inferiority of CHG antiseptic irrigation compared to conventional combined antibiotic irrigation in preventing postoperative ...

2. withpower.com withpower.com/trial/irrisept-vs-antibiotics-for-penile-prosthesis-placement-9fb58

Irrisept vs Antibiotics for Penile Prosthesis Placement The available research does not provide specific data on the effectiveness of Irrisept vs Antibiotics for Penile Prosthesis Placement. Instead, it discusses ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06489431/irrisept-vs-traditional-antibiotic-irrigation-for-virgin-penile-prosthesis-placement

Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile ... The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement.

4. researchgate.net researchgate.net/publication/370634473_Dipping_Titan_implants_in_Irrisept_solution_005_chlorhexidine_gluconate_and_exposure_to_various_aerobic_anaerobic_and_fungal_species

Dipping Titan implants in Irrisept solution (0.05% ... Clinical implications: Irrisept is effective against all of the organisms causing modern-day infections with penile implant surgery and may ...

5. irrisept.com irrisept.com/

Irrisept: Home Irrisept is a self-contained jet lavage delivering low-pressure irrigation. It contains Chlorhexidine Gluconate (CHG), a preservative, to offer broad spectrum ...

6. researchgate.net researchgate.net/publication/367100270_Effect_of_005_chlorhexidine_gluconate_in_water_on_the_hydrophilic_inflatable_penile_prosthesis_biocompatibility_adherence_and_dip_time

Effect of 0.05% chlorhexidine gluconate in water on the ... showed that dipping Titan IPP in Irrisept ® can reduce microorganism colony counts against pathogens that are known to infect penile prostheses ...