SBIR-STTR Award

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.

Public Health Relevance Statement:
Project Narrative More than 100, 000 patients undergo surgery to create a stoma (an opening in the abdominal wall) for treatment of intestinal disease or injury each year in the United States. To decrease the risk of complications, we have developed the LimpetTM, a new device designed as an alternative to conventional pouches used to collect waste from the stoma. Our goal is to deliver a new post-surgical standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions, and save healthcare costs.

Project Terms:
Abdominal; Abdomen; Accidents; Adhesives; ages; Age; Rectal Cancer; Rectal Carcinoma; Rectum Cancer; Rectum Carcinoma; Clinical Trials; Ulcerative Colitis; Ulcerated Colitis; Crohn's disease; Crohn disease; Crohn's; Crohn's disorder; Granulomatous Enteritis; eleocolitis; regional enteritis; Diverticulitis; Edema; Dropsy; Hydrops; Feces; stool; Fistula; Goals; Hand; hands; Health; Healthcare Systems; Health Care Systems; Hospitals; Human; Modern Man; Inflammatory Bowel Diseases; Inflammatory Bowel Disorder; inflammatory disease of the intestine; inflammatory disorder of the intestine; intestinal autoinflammation; Intestinal Diseases; Intestinal Disorder; intestine disease; intestine disorder; Intestinal Obstruction; Bowel Obstruction; intestine obstruction; Intestines; Intestinal; bowel; Length of Stay; Number of Days in Hospital; hospital days; hospital length of stay; hospital stay; Manuals; Minnesota; Ostomy; surgical construction of a stoma; Patient Discharge; Discharge from Health Care Facility; Discharge from Healthcare Facility; Patients; Pelvis; Pelvic; Pelvic Region; pressure; Production; Research; Risk; Safety; seal; Standardization; Surgical sutures; Sutures; Swelling; Technology; Testing; Tissues; Body Tissues; Traction; United States; United States Centers for Medicare and Medicaid Services; Centers for Medicare and Medicaid Services; Health Care Financing Administration; United States Health Care Financing Administration; Vacuum; Work; Health Costs; Healthcare Costs; Health Care Costs; Device Designs; Device Safety; Health Benefit; Prosthetic device; Prosthetics; Prosthesis; injuries; Injury; improved; Procedures; Otomy; incision; Surgical incisions; Clinical; repair; repaired; Phase; Medical; Ensure; Blood flow; wasting; randomized control trial; Randomized, Controlled Trials; Therapeutic; fluid; liquid; Liquid substance; Stomas; Life; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; biomaterial compatibility; biocompatibility; experience; Performance; hospital readmission; hospital re-admission; re-admission; re-hospitalization; readmission; rehospitalization; Sterility; sterile; novel; Agreement; Devices; Colon Carcinoma; Colon Cancer; cancer in the colon; Reporting; abdominal wall; tissue oxygenation; tissue oxygen saturation; patient safety; Skin; preventing; prevent; BMI; BMI percentile; BMI z-score; Quetelet index; Body mass index; Data; International; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Process; Colorectal Cancer; Colo-rectal Cancer; cost; healing; designing; design; Outcome; manufacturing process; Population; Trauma; innovate; innovative; innovation; clinical significance; clinically significant; trial comparing; commercialization; standard of care; efficacy testing; Secure; manufacturability; Intestinal Leakage; Leaky Gut; injury to the intestines; intestinal injury; wound assessment; wound monitoring; wound care; military service; cutaneous damage; dermal damage; skin damage; high BMI; high body mass index; homes; Home; design verification; design validation; manufacturing capabilities; manufacturing capacity; manufacture; manufacturing test

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.

Public Health Relevance Statement:
Narrative More than 100,000 patients undergo surgery to create a stoma (an opening in the abdominal wall) for treatment of intestinal disease or injury each year in the United States. To decrease the risk of complications, we have developed the LimpetTM, a new device designed as an alternative to conventional pouches used to collect waste from the stoma. Our goal is to deliver a new post-surgical standard of care to improve ostomy patient outcomes, shorten hospital stays, reduce readmissions, and save healthcare costs. Terms: