Contamination resistant interconnection for reducing peritoneal dialysis - associated peritonitis

Abstract Significance: Peritonitis remains a significant challenge in the management of end stage renal disease (ESRD) for patients on peritoneal dialysis (PD) and contributes significantly to morbidity and mortality. More than half of these infections result from bacteria originating on skin or mucous membranes, suggesting patient or caregiver contamination as the source of infections. Furthermore, reviewed literature, results from a 6 center survey and 57 interviews with PD providers all suggest contamination during connection for therapy as a common root cause of peritonitis. Patient factors are important in contamination control as existing strategies focus on patient training and depend on patient compliance to be successful. However, fewer than 50% of patients remain compliant to these trainings after 6 months of starting PD. Innovation: The proposed product is a low cost, low risk and patient friendly connection interface that can prevent contamination without dependence on patient compliance. Connection for therapy in this design occurs within an enclosure that shields from touch and aerosol contamination. Scientific Premise: This project is based on the hypothesis that eliminating touch and airborne contamination will reduce peritonitis by up to 50%, the current infection rate by organisms colonizing the skin or mucous membranes. Preliminary Data: Applicant has performed bench experiments demonstrating proof of concept for the contamination resistant interconnection and the in vitro microbiology test method. STTR Phase I Project Objective: Demonstrate feasibility of a contamination resistant PD interconnection that reduces bacterial transfer to dialysis fluid path. Aim 1: Freeze design for contamination resistant interconnection. Contamination resistant interconnection design will be finalized to meet human use requirements based on Aim 1 PD design inputs from clinical experts and patient usability study. Contamination resistant interconnection design will be built, assessed, refined and finalized for Aim 2 testing. The bench testing will follow test protocols and standards utilized in 510K summaries of similar, predicate interconnection devices. Aim 1 will focus on meeting design requirements for leak resistance, fluid flow, and usability. Milestone: Bench testing will demonstrate the potential for meeting Aim 2 success criteria. Aim 2: Contamination resistant interconnection feasibility testing. The objective is to demonstrate feasibility to support STTR Phase II further research, which will focus on contamination resistant interconnection design verification testing (DVT) for FDA submissions and clinical studies. The Aim 1 design will be evaluated with bench tests (n = 10 devices per test) and a simulated touch and aerosol contamination protocol using 2 commonly implicated bacterial strains. The Aim 1 final design will be compared for contamination to an FDA cleared and marketed connection interface in the microbiology testing (n = 20/group with 2 groups). Milestone: The contamination resistant PD connection will demonstrate feasibility by meeting Aim 2 test success criteria.Narrative The objective of this project is to develop an interconnection that reduces contamination during connection for peritoneal dialysis therapy, a major source of peritonitis as suggested by over 50% of episodes from skin and mucous membrane bacteria. The proposed contamination control innovation is a low cost, low risk and patient friendly interconnection that can prevent contamination without dependence on patient compliance, and has the potential to reduce peritoneal dialysis associated peritonitis.