“Dipping Time” for Irrisept Solution on Titan Inflatable Penile Prosthesis Hydrophilic Coating: No Difference From 1 to 60 minutes

Abstract

ABSTRACT Introduction Since hydrophilic coated penile prostheses (PP) first came out, people have discussed how long should the PP be submerged in whatever solution the surgeon decided to “dip” the implant into hoping for the solution to absorb onto the coating of the PP. There has been much discussion and several studies on different antimicrobial agents to soak the Titan PP into. Irrisept is FDA approved to irrigate surgical wounds and company statements appear to show that 99.9% of bacteria and fungus are covered by the solution. Objective For the first time in the known literature, we evaluate dipping time of the hydrophilic coating of the Titan PP. Methods The Titan PP was soaked in Irrisept solution or normal saline for 1, 15, 30 and 60 minutes. All parts were placed in a 35°C oven for 15 minutes to dry before Congo Red Dye test. Congo Red Dye testing was performed per test method VV-0199713, which is the approved FDA test for ensuring product reliability. The testing was done by an independent third company. Results There was no noticeable effect or difference of coating adherence between different soaking times for Irrisept solution or normal saline. Pre-connected IPP products including both pumps and cylinders were tested. (Figure 1 Congo Red stain) Conclusions There appears to be no difference in soaking time from 1, 15, 30 or 60 minutes for Irrisept solution or normal saline. Biocompatibility and long-term device performance have not been verified using the Irrisept solution. Disclosure Yes, this is sponsored by industry/sponsor: Coloplast Clarification Industry initiated, executed and funded study Any of the authors act as a consultant, employee or shareholder of an industry for: Coloplast