Perioperative hemorrhage remains the major complication of transurethral and open prostatic surgical procedures. Significant blood loss from these procedures causes delayed healing and longer hospitalization which significantly increases the cost of patient care. Moreover, prolonged urethral catheterization due to significant post-operative hematuria is one of the major causes of discomfort and increases the morbidity to the patients after prostatic surgery. Our goal is to develop a novel chitosan endoluminal hemostatic dressing (CEHD) that is able to be delivered by a catheter to control and prevent prostatic bleeding via transurethral application enabling significant reduction in catheter indwelling time and providing for reduced length of hospital stay following prostatic surgery. In our Phase I study we successfully demonstrated: 1) development of a safe and effective hemostatic chitosan CEHD for transurethral delivery;2) incorporation of the CEHD as part of a urinary catheter device;3) determination of transurethral operational procedures and protocols in deployment of the CEHD;and 4) demonstration of the feasibility of CEHD for hemorrhage control via transurethral application in a swine bladder neck injury model. The Phase I study results demonstrated significant control of bleeding from bladder neck injury in the first 3 hours with lower red cell counts in urine after the CEHD device deployment compared to controls in the in vivo model. In the Phase II application, through systematic final prototype improvements, we propose to finalize the CEHD design and complete pre-clinical efficacy and safety studies in support of an IDE application. The proposed Phase II study includes: 1) modifications to the CEHD to enhance tissue adhesion and material dissolution;2) finalization of the the CEHD to provide for manufacturability;3) demonstration of ease of CEHD delivery 4) demonstration of safety and efficacy in vivo.
The CEHD development will rapidly control bleeding and enable reduction in hospital days required for observation following prostatectomy. As well as reducing discomfort associated with extended catheterization, the CEHD development has the potential to significantly reduce the overall cost of hospitalization associated with bleeding following prostatectomy by hundreds of millions of dollars. This development will reduce prostatectomy related morbidity and assist with reduction in mortality