Chitosan Endoluminal Hemostatic Dressing

描述（由申请人提供）：HemCon，Inc. PA-08-051壳聚糖腔内止血敷料项目总结摘要P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy摘要本提案的目的是证明可通过Foley导管输送的壳聚糖腔内止血敷料（CEHD）在猪模型中控制和预防尿道出血的I期可行性。该猪模型是与经尿道前列腺切除术（TURP）相关的阻断出血的功效的模型。TURP是治疗良性前列腺增生（BPH）的首选手术方法。在美国，TURP每年约进行10万次。TURP术后出血是导致导管插入时间延长和住院时间延长的主要原因之一，发生在6-10%的患者中。我们的设备将用于通过导管放置相对便宜的专有绷带，以防止长时间出血。这将允许早期导管移除，改善患者舒适度，加速恢复，并由于缩短住院时间而显著降低住院费用。HemCon开发了专有的基于壳聚糖的敷料，并获得FDA批准用于控制出血，特别是在战场上。我们将HemCon敷料用作CEHD，使其能够用于TURP手术中控制出血并促进手术。HemCon敷料的改进是壁厚减少（从1.2 mm减少到~200 μ m）和耐溶解性改善。在本I期提案中，我们将：i）进一步完善CEHD，使其可以通过Foley导管应用于切除的前列腺表面，在存在尿液的情况下保持原位长达72小时，以控制血流;和ii）通过比较TURP猪模型中血尿的严重程度和持续时间来测试绷带的功效。本研究的可行性标准为：i）与当前实践标准相比，CEHD显示在前24小时内出血显著减少; ii）与实践标准相比，CEHD组的损伤感染或炎症没有显著增强; iii）CEHD可以通过用低pH冲洗液溶解而去除。II期研究将导致FDA提交临床试验。 公共卫生相关性：HemCon Medical Technologies，Inc. PA-08-051壳聚糖腔内止血敷料项目叙述P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy项目叙述前列腺腔出血是切除肥大前列腺组织治疗良性前列腺增生（BPH）的主要并发症。由于术后大量出血而导致的长时间导尿大多会导致患者不适，并增加尿路感染和其他慢性并发症的风险。本项目的动机是基于我们成功的壳聚糖止血敷料原型，开发一种创新的腔内壳聚糖止血敷料，以控制和预防前列腺出血，缩短前列腺手术后的导尿时间。我们的长期目标是提供一种安全，有效和方便的技术来治疗和预防前列腺手术出血。

DESCRIPTION (provided by applicant): HemCon, Inc. PA-08-051 Chitosan Endoluminal Hemostatic Dressing Project Summary Abstract P.I. - Hua Xie Page 1 Co-PI - Simon McCarthy Abstract 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 <m) and improvement in resistance to dissolution. In this Phase I proposal we will: i) further refine the CEHD so that it can be applied by a Foley catheter to the resected prostrate surface to stay in place for up to 72 hours to control blood flow in the presence of urine; and ii) test the efficacy of the bandage by comparing severity and duration of hematouria in the swine model of TURP. Feasibility criteria in this study will be: i) the CEHD demonstrates significantly reduced bleeding in the first 24 hours compared to current standard of practice; ii) there is no significant enhancement in injury infection or inflammation in the CEHD group compared to standard of practice; iii) the CEHD can be removed by dissolution with a low pH irrigation solution. Phase II studies will lead to an FDA submission for clinical trials. PUBLIC HEALTH RELEVANCE: 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.