(141) COMPARATIVE STUDY DIPPING TITAN IMPLANTS IN IRRISEPT (0.05% CHG) SOLUTION, VANCOMYCIN/GENTAMICIN OR SALINE CONTROL AND EXPOSURE TO VARIOUS MICROBIAL SPECIES
Authors: Karpman E , Griggs R , Twomey C , Henry GD 
Published: December 2024

Introduction

Infection retardant coated implants have significantly decreased penile prosthesis infection (PPI) since their release in 2001. However, the microbial spectrum of PPI has significantly changed since then based on recent literature reports of PPI. Gram negative and fungal species are now included in the three most common organisms isolated during PPI. Irrisept® is a 0.05% chlorhexidine gluconate (CHG) antiseptic solution that has been shown to be effective at treating the most common aerobic, anaerobic and fungal species causing PPI in a recent publication. The study simulated the real world practice of dipping and irrigating penile implants with an antimicrobial solution. However, the study was compared to saline control only. Here we present the results from the largest comparative study of Irrisept® solution, Vancomycin/Gentamicin (V/G) and a saline control on microbial reduction in hydrophilic coated implants.

Objective

Evaluate the microbial reduction by Irrisept®, V/G and saline dipped and irrigated Titan® implant discs.

Methods

The previously published protocol was used adding a V/G arm. (Figure 1 and 2) An in-vitro microbial reduction evaluation of the ability of an irrigation solution and device or V/G to remove transient bacterial contamination from a test substrate - pre-cut discs prepared from a penile implant material. Three microorganisms - Escherichia coli (A TCC #25922), Pseudomonas aeruginosa (ATCC #27853), and Staphylococcus aureus (ATCC #25923) were used for this evaluation. For each challenge species, three discs of the implant material (i.e., Baseline Carriers) were pre-conditioned by immersion in 0.9% Sodium Chloride Irrigation, USP (Baseline Controls), three discs were pre-conditioned by immersion in the irrigation solution (Irrisept®) and three discs in V/G; (i.e., Test Carriers). The pre-conditioned carriers were allowed to dry for approximately 10 minutes prior to contamination with a suspension of each test strain. Following a 2-to-3-minute drying period at room temperature, the three contaminated Baseline Carriers were evaluated for viable microbial recoveries, three of the contaminated and dried Test Carriers were evaluated for viable microbial recoveries with no additional treatment (Pre- Rinse Test Carriers), and the three remaining Test Carriers were evaluated following a rinsing procedure using the wound irrigation device/solution, V/G or saline (Post-Rinse Test Carriers).

Results

Table 1 presents the Initial Populations (CFU/mL), the Mean Baseline Control Recoveries (log10), the Mean Pre-Exposure Reduction (log10) and the mean Post-Exposure Recovery (log10) of Escherichia coli (ATCC #25922), Pseudomonas aeruginosa (ATCC #27853), and Staphylococcus aureus (ATCC #25923) produced by the wound irrigation device/solution (lrrisept® 450 mL [Lot #21HDB982]), V/G or saline following three rinses/irrigations. Irrisept® was more effective than V/G and saline in reducing microbial counts in all the organisms tested.

Conclusions

Irrisept® dipped and irrigated Titan® discs are shown to kill all the tested bacteria better than V/G or saline. The log reduction in bacterial species is consistent with the known efficacy of V/G and Irrisept® in other studies. Further comparative clinical studies are needed to evaluate the best solution for dipping and irrigating hydrophilic coated penile implants.

Disclosure

Yes, this is sponsored by industry/sponsor: Coloplast and Irrimax.

Clarification: Industry funding only - investigator initiated and executed study.

Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast, Irrimax.