Chitosan Endoluminal Hemostatic Dressing

描述（申请人提供）：HemCon, Inc。摘要本课题的目的是在猪模型上验证壳聚糖腔内止血敷料（CEHD）的I期可行性，该敷料可通过Foley导管输送，以控制和预防尿道出血。该猪模型是阻断经尿道前列腺切除术（TURP）相关出血的疗效模型。TURP是良性前列腺增生（BPH）的一线手术治疗方法。在美国，每年进行大约10万次TURP。TURP术后出血是延长置管和住院时间的主要原因之一，发生率为6-10%。我们的设备将通过导管放置一个相对便宜的专有绷带，以防止长期出血。这将允许早期拔除导管，改善患者舒适度，加速恢复，并因住院时间缩短而显着降低医院费用。专有的壳聚糖敷料由HemCon公司开发，并获得FDA批准用于控制出血，特别是在战场上。我们已经将HemCon敷料改造为CEHD，使其能够在TURP手术中用于控制出血和促进手术。HemCon敷料经过改进后，其壁厚减少（从1.2 mm降至~200 <m），抗溶解性提高。在这个第一阶段的建议中，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，并在那里停留长达72小时，以控制尿液存在时的血流；ii)通过比较猪TURP模型血尿的严重程度和持续时间来检验绷带的有效性。本研究的可行性标准将是：i)与目前的实践标准相比，CEHD在头24小时内显着减少出血；ii)与标准做法相比，CEHD组的损伤感染或炎症没有显著增加；iii)用低酸碱度的灌溉溶液溶解可去除CEHD。II期研究将导致FDA提交临床试验。

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.