Porous Biomaterials to Resist Percutaneous Infection

Focus: 

To test the ability of a catheter to prevent short-term infection

Anticipated Impact: 

Reduced infection in short- and long-term catheter placements

Abstract: 

Catheters are essential devices in health-care delivery. However, the skin exit wounds are prime sites for infections that compromise device usefulness and put patients at serious risk. The target product is a porous biomaterial cuff to reduce exit site infections of central venous catheters (CVCs) for hemodialysis (HD). Nationwide over 80% of end-stage renal disease (ESRD) patients start HD with these catheters. Frequently they are in long-term chronic use, with more than 100,000 HD patients currently receiving dialysis this way. Infection rates are very high, up to 10/1000 catheter-days. Nearly 50% of these are associated with exit site bacterial pathways. In 2011 there were 5500 dialysis patients in Washington. Local renal care is significantly better than the national average, but at any time about 450 of these patients are using catheters for more than 90 days, incurring high risk of serious infection and death. A 25% reduction in catheter-related infections would save more than $20 million annually in treatment costs in Washington alone. Nationwide, savings to Medicare/Medicaid could exceed $1 billion of the $30 billion annual cost of ESRD treatment. To address exit site issues, Dr. Fleckman and his group collaborated with the University of Washington Engineered Biomaterials (UWEB) program to develop biomaterials into which skin heals with full viability. UWEB invented a porous structure (Sphere Templated Angiogenic Regenerative, or STAR) that strongly exhibits this desirable property. The patented technology is exclusively licensed to Seattle-based Healionics for commercialization. Under NIH funding, the team developed a well characterized mouse model to study the biology of the cutaneous interface with STAR material. However, the "gold standard" for demonstrating material effectiveness to impede infection at device exit sites is resistance to bacterial challenge. A previous LSDF commercialization grant demonstrated feasibility of modifying the mouse model for bacterial challenge studies. The current grant will use this model to test the ability of a second-generation, granular STAR material to resist bacterial infection at catheter exit sites. These studies will strengthen applications for US and European regulatory approval of catheters coated with STAR material. In parallel with the scientific activities, Healionics is pursuing strategic alliances with HD CVC device manufacturers.

Collaborating organization: Healionics

Catheter-Related Infection Prevention

Grant Update

Principal Investigator:
Philip Fleckman
Grantee Organization:
University of Washington
Grant Title:
Porous biomaterials to resist percutaneous infection
Grant Cohort and Year:
2011 Second Round Commercialization (04)
Grant Period:
10/01/2012 - 09/30/2014 (Completed)
Grant Amount:
$139,223
Experiments to demonstrate resistance to infection by STAR material implanted in mice and challenged externally demonstrate that while long-term (28 day) resistance to challenge is not supported in this system, short-term advantage has been demonstrated.

Impact in Washington

Location of LSDF Grantee
Locations of Collaborations/Areas of Impact
Seattle

Legislative Districts:
11, 34, 36, 37, 43, 46

Health Impacts

Catheter-Related Infection Prevention