SBIR-STTR Award

The goal of this proposal is to demonstrate Phase I feasibility of a chitosan endoluminal hemostatic dressing (CEHD) that can be delivered through a Foley catheter to control and prevent urethral bleeding in a swine model. This swine model is a model of efficacy of blocking hemorrhage associated with transurethral resection of the prostate (TURP). TURP is the first line surgical treatment for benign prostate hyperplasia (BPH). TURP is performed about 100,000 times per year in the US. Post-operative hemorrhage after TURP is one of the major causes of prolonged catheterization and hospitalization, occurring in 6-10% of patients. Our device will be used to place a relatively inexpensive proprietary bandage via the catheter to prevent prolonged bleeding. This would allow for early catheter removal, improved patient comfort, accelerated recovery and significantly reduced hospital costs due to shorter hospital stays. Proprietary chitosan based dressings have been developed by HemCon and are FDA approved for controlling hemorrhage, especially on the battlefield. We have adapted the HemCon dressing as the CEHD to enable it to be used to control bleeding and facilitate surgery in the TURP procedure. Modifications to the HemCon dressing have been reduction in wall thickness (from 1.2 mm to ~200

Public Health Relevance Statement:
HemCon Medical Technologies, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Narrative P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Project Narrative Bleeding from prostatic cavity is the major complication in resection of enlarged prostatic gland tissue for the treatment of benign prostatic hyperplasia (BPH). Prolonged urethral catheterization due to significant post-operative bleeding mostly causes discomfort of the patients and increases the risk of urinary infection and other chronic complications. The motivation of this project, based upon our successful prototype of chitosan hemostatic dressing, is to develop an innovative endoluminal chitosan hemostatic dressing to control and prevent the prostatic bleeding and shorten the catheterization time after prostatic surgery. Our long-term goal is to provide a safe, effective and convenient technique to treat and prevent the bleeding from prostatic surgeries.

NIH Spending Category:
Urologic Diseases

Project Terms:
abstracting; Acute; Adhesions; Animal Model; Animals; Bandage; base; Benign Prostatic Hypertrophy; Blood; Blood flow; Blood Pressure; Catheterization; Catheters; Chitosan; Chronic; Clinical Trials; Complication; Devices; efficacy testing; Excision; experience; Failure (biologic function); Family suidae; FDA approved; Goals; Hematuria; Hemorrhage; Hemostatic Agents; Hospital Costs; Hospitalization; Hour; improved; In Vitro; in vitro testing; in vivo; Infection; Inflammation; Injury; innovation; Irrigation; Lead; Length of Stay; Maintenance; Measures; Medical Technology; meetings; Modeling; Modification; Motivation; Operative Surgical Procedures; Patients; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Postoperative Hemorrhage; Postoperative Period; pre-clinical; prevent; Procedures; Property; Prostate; prostate transurethral resection; Prostatic; prototype; public health relevance; Reaction; Recovery; Relative (related person); research study; Resected; Resistance; Risk; Severities; Solutions; standard of care; Sterile coverings; Stress; success; Surface; Techniques; Testing; Thick; Time; Tissues; trend; Urethra; Urethral Catheterization; urinary; Urine; Visual

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.

Public Health Relevance Statement:


Public Health Relevance:
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

Project Terms:
Acute; Adherence (attribute); Adhesions; Adhesives; Anesthesia procedures; Animals; Area; arm; Bandage; biomaterial compatibility; Bladder Injury; Blood; Catheterization; Catheters; Cell Count; Chitosan; clinical efficacy; Clinical Research; Complication; cost; design; Development; Devices; Drug Formulations; Economic Inflation; Erythrocytes; Excision; Family suidae; Goals; Hematuria; Hemorrhage; Hemostatic Agents; Hemostatic function; Hospitalization; Hour; Impaired wound healing; In Vitro; in vivo; in vivo Model; Indwelling Catheter; Infection; injured; Injury; Left; Length of Stay; Leukocytes; Maintenance; Mechanics; Medical Device; meetings; Modeling; Modification; Morbidity - disease rate; Mortality Vital Statistics; Movement; Neck Injuries; novel; Obstruction; Operative Surgical Procedures; Pain; Patient Care; Patients; Perioperative; Phase; phase 1 study; phase 2 study; Physiological; Postoperative Period; pre-clinical; Preparation; pressure; prevent; Procedures; product development; Property; Prostatectomy; Prostatic; Protocols documentation; prototype; public health relevance; Reaction; Red Blood Cell Count measurement; Relative (related person); Resistance; Safety; safety study; Site; standard of care; Sterile coverings; success; Surface; Temperature; Testing; Time; Tissues; Urethra; Urethral Catheterization; urinary; urinary bladder neck; Urine; Visual; White Blood Cell Count procedure; Wound Healing