Irrisept vs Antibiotics for Penile Prosthesis Placement

Recruiting at1 trial location

Overseen by Laurence Levine, MD

Age: Any Age

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rush University Medical Center

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess whether intraoperative irrigation with Irrisept is not inferior to irrigation with multiple antibiotics during placement of a first time inflatable penile prosthesis device.

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.

What data supports the idea that Irrisept vs Antibiotics for Penile Prosthesis Placement is an effective treatment?

The available research does not provide specific data on the effectiveness of Irrisept vs Antibiotics for Penile Prosthesis Placement. Instead, it discusses other treatments for infections related to prosthetic implants, such as conservative therapy with antibiotics and irrigation and debridement methods. These studies highlight the challenges and varying success rates of managing infections with these treatments, but they do not directly compare Irrisept to antibiotics for penile prosthesis placement. ^{1 2 3 4 5}

What safety data exists for Irrisept and antibiotic irrigation in penile prosthesis placement?

The safety data for Irrisept and antibiotic irrigation in penile prosthesis placement includes: 1) A study indicating that a new surgical irrigation solution, FDA-cleared as antimicrobial wound lavage, appears safe and noncaustic for patients during hydrophilic inflatable penile prosthesis procedures. 2) The use of 0.05% chlorhexidine gluconate (Irrisept) in salvage procedures for penile prostheses, which has been reported in the literature as part of various techniques. 3) A review of 269 patients showing a low infection rate (1.9%) with the use of perioperative antibiotics, intraoperative shave, and strict surgical techniques, although some patients with predisposing conditions still faced infection risks. ^{6 7 8 9 10}

Is Irrisept a promising treatment for penile prosthesis placement?

The information provided does not directly address the effectiveness of Irrisept for penile prosthesis placement. The articles focus on other treatments and infections related to joint prostheses, not specifically on Irrisept or penile prosthesis placement. ^{2 11 12 13 14}

Research Team

Edward Cherullo, MD

Principal Investigator

Rush University

Laurence Levine, MD

Principal Investigator

Rush University

Eligibility Criteria

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.

Treatment Details

Interventions

• Irrisept (Antibiotic)
• Traditional Antibiotic Irrigation (Antibiotic)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Dr. Omar B. Lateef

Rush University Medical Center

Chief Executive Officer since 2022

MD from Des Moines University, Fellowship in Pulmonary and Critical Care Medicine at Rush University Medical Center

Dr. Paul E. Casey

Rush University Medical Center

Chief Medical Officer since 2021

MD, MBA

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Conservative Therapy is an Effective Option in Patients With Localized Infection After Penile Implant Surgery. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Recurrent Periprosthetic Joint Infection After Irrigation and Debridement With Component Retention Is Most Often Due to Identical Organisms. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Irrigation and Debridement With Chronic Antibiotic Suppression for the Management of Acutely Infected Aseptic Revision Total Joint Arthroplasties. [2023]

4. Switzerland 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. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Early prosthetic joint infection: outcomes with debridement and implant retention followed by antibiotic therapy. [2011]

6. England pubmed.ncbi.nlm.nih.gov

Treatment alternatives for the infected penile implant. [2010]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of 0.05% chlorhexidine gluconate in water on the hydrophilic inflatable penile prosthesis: biocompatibility, adherence, and dip time. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Three piece penile prosthesis salvage with chlorhexidine gluconate and length preservation: our technique and outcomes. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Risk factors associated with penile prosthesis infection. [2019]

11. United Arab Emirates 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. [2022]

12. Switzerland 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. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Irrigation and debridement for periprosthetic infections: does the organism matter? [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Long-term suppression of infection in total joint arthroplasty. [2005]