Does Irrisept Dipping/Irrigation Adversely Affect the Hydrophilic Coating of Titan Implants?

Abstract

ABSTRACT Introduction Prosthetic infections occur in 1-3% of virgin implants. Titan penile prostheses (PP) have a hydrophilic coating that can absorb any antibiotic/antifungal solution for infection prevention. The ideal solution for dipping non-coated implants is yet to be described, however, reports of various solutions exist. Chlorhexidine gluconate is a very broad spectrum antibacterial, antifungal and antiviral solution that has been used for skin preparation for surgery because of its excellent profile for known pathogens. Irrisept is the first and only chlorhexidine 0.05% solution that has been FDA cleared for intra-corporal wound lavage in humans. When considering a new dipping solution, we must always weigh the effectiveness of any dipping solution with the caustic properties of the solution on the device and tissue. Objective The purpose of this experiment is to determine the effects of Irrisept solution on Coloplast's hydrophilic coating incorporated on the Titan penile prosthesis (PP). Methods Pre-connected Titan PP product including both pumps and cylinders were tested. The Titan PP was soaked in Irrisept solution and normal saline for 1, 15, 30 and 60 minutes. After soaking, all parts were dried for 15 minutes in a 35°C oven, and then went through the Congo Red Dye Test. Congo Red dye testing was performed per the approved FDA test method for ensuring product reliability. (Coloplast’ internal Test Method.) Results All the PPs tested achieved satisfactory coating results. There was no noticeable effect or difference of coating adherence between the saline soaked control and Irrisept soaked devices. And there was no noticeable effect or difference of coating adherence between different soaking time. (Figure 1 Congo Red stain) Conclusions Soaking the Titan PP in Irrisept solution does not effect the hydrophilic coating of the implant when compared to saline. There was also no difference in hydrophilic coating compared to saline controls at various times of dipping (1, 15, 30 and 60 min). 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