Novel Post-surgical Incision Management Device to Prevent Ostomy Complications

项目摘要/摘要 在美国，由于各种原因，每年有超过10万名各个年龄段的患者接受造口手术 病理生理状况，包括结直肠癌、炎症性肠病(克罗恩病和 溃疡性结肠炎)、肠梗阻、憩室炎和许多其他疾病。造口手术也可能 在因意外或受伤而导致严重腹部或骨盆创伤的情况下是必要的 在服兵役期间。造口手术是一种挽救生命的手术，它允许身体排泄物通过手术进入 在腹部创造了一个称为造口的开口，进入一个假体中，这个假体被称为‘袋’或‘造口袋’。 在身体之外。患者在造口后几天内出院，预计 在家中使用一次性造口袋附着在造口周围的皮肤上进行治疗。不幸的是，目前 眼袋设计对术后水肿(肿胀)几乎没有治疗作用，而且可能无法保持紧密的密封， 允许肠液和排泄物泄漏。由此导致的吻合口并发症包括黏膜皮肤 (皮肤/吻合口)分离、吻合口回缩和湿气相关的皮肤损伤。高达70%的造口患者 忍受这些并发症，其中29%的患者需要再次住院，额外花费 每个病人78,000美元。此外，高体重指数(BMI)患者出现并发症的风险更高。 考虑到需要进行造口手术的临床情况的增加，美国人口BMI的增加，以及 目前的报销格局惩罚了再次入院的医疗保健系统，改善了后 手术切开处理装置，以预防造口并发症是迫切需要的。在此SBIR中直接 第二阶段，瘘管解决方案将开发一种新的术后造口切口管理装置，旨在 防止并发症，形成紧密的密封，保护新的吻合口。这个装置可以稳定周围的组织 吻合口可以减少水肿和缝线上的张力，同时将皮肤/吻合口连接在一起，便于 治愈。此外，该设备还创建了安全密封件，以阻止粪便泄漏和预防MASD。我们的具体目标 1)为可制造性和临床效益优化产品设计；2)验证产品设计和 生物相容性；以及3)进行临床试验，将该装置与传统的粘合剂造口袋进行比较 与明尼苏达州圣保罗的HealthPartners Institute和Regions医院合作。成功地执行我们的 具体目标将确定设备的安全性和有效性，并确保设备的设计可制造性 和生物兼容性。人类健康福利是改善造口患者预后的新护理标准， 缩短住院时间，减少再次住院，并减轻医院的重大财务风险。

Project Summary/Abstract Over 100,000 patients of all ages undergo ostomy surgery in the United States (US) annually due to a variety of pathophysiologic conditions including colorectal cancer, inflammatory bowel disease (Crohn’s disease and ulcerative colitis), bowel obstruction, diverticulitis, and many other medical conditions. Ostomy surgery may also be necessary in cases of severe abdominal or pelvic trauma resulting from accidents or from injuries sustained during military service. A life-saving procedure, ostomy surgery allows bodily waste to pass through a surgically created opening called a stoma on the abdomen into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. Patients are discharged from the hospital within days of ostomy creation and expected to heal at home using disposable ostomy pouches attached to the skin around their stoma. Unfortunately, current pouch designs offer little therapeutic benefit for post-surgery edema (swelling) and may not maintain a tight seal, allowing leakage of intestinal fluid and waste. Resulting stoma complications include mucocutaneous (skin/stoma) separation, stoma retraction, and moisture-associated skin damage. Up to 70% of ostomy patients endure these complications, with 29% of these patients requiring hospital readmissions at an additional cost of $78,000 per patient. Furthermore, risks for complications are higher for high body mass index (BMI) patients. Given the rise in clinical conditions requiring ostomy surgery, the increased BMI of the US population, and the current reimbursement landscape that penalizes the healthcare system for readmissions, an improved post- surgical incision management device to prevent ostomy complications is urgently needed. In this SBIR Direct Phase II, Fistula Solution will develop a novel post-surgical ostomy incision management device designed to prevent complications, form a tight seal, and protect the new stoma. This device stabilizes the tissue around the stoma to reduce edema and tension on sutures, along with holding the skin/stoma junction together to facilitate healing. In addition, the device creates a secure seal to stop stool leaks and prevent MASD. Our specific aims are to 1) optimize product design for manufacturability and clinical benefits; 2) verify product design and biocompatibility; and 3) conduct a clinical trial comparing the device to conventional adhesive ostomy pouches with HealthPartners Institute and Regions Hospital in St. Paul, Minnesota. The successful execution of our specific aims will establish device safety and efficacy and ensure the device is designed for manufacturability and biocompatibility. The human health benefit is a new standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions to hospital, and mitigate a major financial exposure for hospitals.