A Mobile App for Wound and Symptom Surveillance After Colorectal Surgery: Protocol for a Feasibility Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Surgical site infections (SSIs) are the most common nosocomial infection and occur in 16.3% of patients undergoing colorectal surgery at our institution (The Ottawa Hospital), the majority of which are identified after discharge from hospital. Patients who suspect having an SSI generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the health care system and patients. A mobile app, how2trak, has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations. OBJECTIVE This study aims to assess the feasibility of a randomized controlled trial to assess if how2trak can improve patients’ experience and increase detection of SSIs after colorectal surgery while reducing patients’ risk of COVID-19 exposure. METHODS In this single-center prospective feasibility trial, eligible patients undergoing colorectal surgery will be randomized to either standard care or how2trak postoperative monitoring of their incision, symptoms, and ostomy function. Patient self-assessments will be monitored by a nurse specialized in wound and ostomy care who will follow-up with patients with a suspected SSI. The primary outcome is feasibility as measured by enrollment, randomization, app usability, data extraction, and resource capacity. RESULTS This study was approved by our institution’s ethics board on February 26, 2021, and received support from The Ottawa Hospital Innovation and Care Funding on November 12, 2021. Recruitment started June 3, 2021, and 29 were patients enrolled as of September 2021. We expect to publish results in spring 2022. CONCLUSIONS This study will determine the feasibility of using a mobile app to monitor patients’ wounds and detect SSIs after colorectal surgery. If feasible, we plan to assess if this mobile app facilitates SSI detection, enhances patient experience, and optimizes their care. CLINICALTRIAL ClinicalTrials.gov NCT04869774; https://clinicaltrials.gov/ct2/show/NCT04869774 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/26717