14 Clinical Trials for Various Conditions
The objective of this study is to elucidate whether the use of an ostomy belt can improve the quality of life in patients with an ostomy.
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches, and to explore the clinical and quality of life benefits that may occur with the use of the test product. A minimum of 30 subjects, and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies.
Negative pressure wound dressings have been studied and shown to have applications in decreasing rates of surgical wound infections. This study studies the effect of a low cost needle-aspirated negative pressure compression dressing on rates of wound infection at prior ostomy site in patients undergoing ostomy reversal surgery.
The purpose of this study is to test the benefits of an educational program, the Ostomy Self-Management Training (OSMT) program, for improving patient activation (preparedness to do self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy self-care, quality of life, mood, use of medical services, and financial burden in patients with ostomies. The study will compare patients in the intervention (training) group and patients in the usual care group. Subjects' participation in this study is expected to last about 7 months. The PI plans to enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be coordinated by the University of Arizona in Tucson, Arizona.
The purpose of this study is to determine the safety and tolerability of NM-IL-12 relative to standard of care (SOC; control) in subjects with open surgical wounds.
In this study the investigators will evaluate the acceptability of a communication intervention for fecal ostomy surgery (CI-oSurg) to address the needs of adults who are undergoing fecal ostomy surgery. The investigators will recruit 24 patients and 4 clinicians (surgical nurses, wound ostomy nurses). At least half of patients are 65 years or older to understand the unique needs of older adults recovering from fecal ostomy surgery that might impact intervention acceptability. Questionnaires will be administered at two time-points for patient participants: upon study start and 4 weeks after exposure to the intervention.
Currently a multiport robotic surgery platform (Intuitive Xi) is widely available and used for colorectal surgery indications. A Single port platform (Intuitive SP) is FDA approved for Head and Neck and Urology but has not been widely used in colorectal surgery. This study seeks to evaluate the safe and effective use of the SP platform for colorectal surgery indications.
Adult patients without prior history of ostomy, undergoing elective surgery involving a new ileostomy or colostomy will be randomized to receive standard ostomy nurse teaching or ostomy nurse teaching combined with preoperative and postoperative stoma care teaching video. Post operative outcomes including delay in discharge and stoma-related complications will be tracked.
In this study, a novel ostomy ring device will be assessed for safety and efficacy in increasing the lifespan of ostomy pouching equipment.
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
The aim of the study is to obtain an understanding of relevant parameters affecting the performance of ostomy products.
This pilot study will explore whether preoperative application of stool from the stoma bag to the perianal area will prevent/ decrease postoperative perianal maceration in pediatric ostomy closure patients. It will also explore the overall safety and feasibility of this pilot study for larger randomized control trials. There will be a control group and an intervention group. The intervention group will apply stool from the stoma bag approximately 4 weeks prior to ostomy closure and fill out a compliance log and upload pictures weekly to the MyCHP (My Children's Hospital) portal. A validated diaper dermatitis score will be utilized in this study.
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures. Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis. Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.