LAUSR

OBJECTIVE To investigate a novel transurethral hemostatic catheter device with an integrated chitosan endoluminal hemostatic dressing (CEHD). Development and implementation of this technology may help address bleeding following surgery such as transurethral resection of prostate (TURP). Bleeding remains the most common complication following TURP, leading to increased morbidity and hospitalization. METHODS Investigation of hemostasis, delivery, safety and efficacy of the CEHD device is conducted using Female Yorkshire swine (N=23). Hemostatic efficacy of the CEHD (N=12) is investigated against a control of gauze (N=12) in a splenic injury model (3 swine). The delivery, safety and efficacy of the CEHD device (N=10) are investigated against Foley-catheter control (N=10) for 7 days using a swine bladder-neck-injury model. RESULTS In the splenic injury study, 9/12 CEHD dressings successfully achieved hemostasis within 150 seconds (mean 83 seconds) versus success of 6/12 (mean 150 seconds) for gauze (p=0.04). In the 7-day study, the CEHD was successfully deployed in 10/10 animals and all dressings were tolerated without histologic or clinical adverse effect. Hemostasis of the CEHD device was found to be non-inferior to control catheters. Non-inferiority is attributed to low bleeding rates in the swine bladder neck injury model. CONCLUSIONS This investigation successfully demonstrated the feasibility of transurethral deployment of the CEHD in vivo. Routine use of safe and slowly dissolvable CEHDs could reduce the rate of complications and hospitalizations associated with bleeding and blood loss in TURP procedures. Further investigation is warranted.