Evaluation of Two Ostomy Seals in Adults After Ostomy Surgery Study of TRE Seals in Early Post-operative Patients

What this Trial Is About

This research aims to evaluate two types of ostomy seals or rings in patients who have recently undergone ostomy surgery. It focuses on preventing and managing complications related to the skin around the stoma, known as peristomal skin complications PSCs. The study is sponsored by Hollister Incorporated and involves post-operative patients with colostomy, ileostomy, or urostomy, assessing how these devices perform in real-world use. Participants will be randomly assigned to use either an absorptive ostomy seal or an ostomy ring containing Aloe. These devices are applied at the first pouch change following surgery or up to four days after the operation. The study treatment period lasts for nine weeks, during which patients use the assigned seal or ring as part of their ostomy care. The trial compares the two devices to monitor skin complications and other related outcomes. During the study, participants will be followed from enrollment through the nine-week treatment phase with regular assessments. Researchers will track skin complications using the Ostomy Complication Severity Index OCSI, including measures of leakage, moisture, skin conditions, and patient and clinician satisfaction. The study also collects data on usage patterns, healthcare visits related to the ostomy, and costs associated with the seals or rings. The overall goal is to understand the devices impact on skin health and patient experience after ostomy surgery.

Study of TRE Seals on Early Post-operative Subjects