Novel Post-surgical Incision Management Device to Prevent Ostomy Complications

预防造口并发症的新型术后切口管理装置

• 批准号: 10590062
• 负责人: Andrew T Obst
• 金额: $ 77.31万
• 依托单位: FISTULA SOLUTION CORPORATION
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-01 至 2026-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10590062
• 关键词: Abdomen; Accidents; Adhesives; Age; Agreement; Blood flow; Body mass index; Clinical; Clinical Trials; Colon Carcinoma; Colorectal Cancer; Crohn' s disease; Data; Device Designs; Device Safety; Devices; Diverticulitis; Edema; Ensure; Feces; Fistula; Goals; Hand; Health; Health Benefit; Health Care Costs; Healthcare Systems; Home; Hospitals; Human; Inflammatory Bowel Diseases; Injury; International; Intestinal Diseases; Intestinal Obstruction; Intestines; Leaky Gut; Length of Stay; Life; Liquid substance; Manuals; Medical; Minnesota; Operative Surgical Procedures; Ostomy; Outcome; Patient Discharge; Patient-Focused Outcomes; Patients; Pelvis; Performance; Phase; Population; Procedures; Process; Production; Prosthesis; Randomized, Controlled Trials; Rectal Cancer; Reporting; Research; Risk; Safety; Secure; Skin; Small Business Innovation Research Grant; Standardization; Sterility; Stomas; Surgical incisions; Surgical sutures; Swelling; Technology; Testing; Therapeutic; Tissues; Traction; Trauma; Ulcerative Colitis; United States; United States Centers for Medicare and Medicaid Services; Vacuum; Work; abdominal wall; biomaterial compatibility; clinically significant; commercialization; cost; design; design verification; efficacy testing; experience; healing; high body mass index; hospital readmission; improved; innovation; intestinal injury; manufacturability; manufacture; manufacturing capabilities; manufacturing process; manufacturing test; military service; novel; patient safety; pressure; prevent; repaired; seal; skin damage; standard of care; tissue oxygenation; trial comparing; wasting; wound care

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.

项目摘要/摘要 由于多种 病理生理状况，包括大肠癌，炎症性肠病（克罗恩病和 溃疡性结肠炎），肠梗阻，憩室炎和许多其他医疗状况。造口外科手术也可能 在因事故或受伤造成的严重腹部或骨盆创伤的情况下，必要 在服兵役期间。挽救生命的过程，造口术手术使身体浪费可以通过外科手术 创建的开口称为腹部的造口，成为一个被称为“小袋”或“造口袋”的假肢 在身体外。患者在造造造口术的几天内从医院出院，预计将 使用胃部附着在皮肤周围的皮肤上的一次性造口袋中治愈。不幸的是，目前 小袋设计对手术后水肿几乎没有治疗效果（肿胀），并且可能无法保持紧密的密封， 允许肠液和废物泄漏。由此产生的地面并发症包括粘膜状 （皮肤/造口）分离，造口回缩和与水分相关的皮肤损伤。多达70％的造口术患者 忍受这些并发症，其中29％需要医院再入院，额外费用为 每位患者$ 78,000。此外，高体重指数（BMI）患者的并发症风险更高。 鉴于需要造口术手术的临床状况升高，美国人群的BMI增加，以及 当前的报销格局惩罚了用于再选中的医疗保健系统，这是一种改善的后 迫切需要进行手术切口管理装置以预防造口术并发症。在这个sbir直接 第二阶段，瘘管解决方案将开发一种新型的手术后造口术切口管理装置，旨在 防止并发症，形成紧密的密封并保护新的造口。该设备稳定了周围的组织 造口以减少成功的水肿和张力，并将皮肤/骨骼连接在一起以促进 康复。此外，该设备会创建一个安全的密封，以阻止凳子泄漏并防止MASD。我们的具体目标 到1）优化产品设计以实现制造和临床福利； 2）验证产品设计和 生物相容性； 3）进行一项临床试验，将设备与常规粘合性造口术进行比较 与明尼苏达州圣保罗的HealthPartners研究所和地区医院一起。我们的成功执行 具体目标将建立设备安全和效率，并确保该设备设计用于制造 和生物相容性。人类健康益处是改善造口术患者结局的新标准， 缩短医院住院，减少住院再入院，并减轻医院的重大财务曝光率。