NCT04869774

Wound And Symptom Tracking After Colorectal Surgery Using How2trak

A Mobile Application for Wound and Symptom Surveillance After Colorectal Surgery: a Feasibility Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University of Ottawa · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the feasibility of using a mobile application (app) called how2trak to improve people's experience, wound surveillance, and detection of surgical site infections (SSI) after colorectal surgery while reducing in-person interactions for patients during the COVID-19 pandemic. This will inform the implementation of a full-scale trial to establish if surveillance of someone's incision and symptoms using how2trak improves SSI detection and management compared to standard care (involving a single post-operative surgery clinic visit). The data collected will contribute to a broader dataset of people with SSI surveillance to be used in developing a clinical decision support system.

Detailed description

Background: Surgical site infections (SSI) are the most common nosocomial infection and occur in 16.3% of individuals undergoing colorectal surgery at our institution, the majority of which are identified after discharge from hospital. Patients concerned to have an SSI, generally present to the emergency department or surgery clinic. Both options for in-person interaction are costly to the healthcare system and patients, and increase their risk of COVID-19 exposure. A mobile application How2trak has proven to be beneficial for patients with complex wounds at our institution by facilitating at-home monitoring and virtual consultations. Aim: This study aims to assess the feasibility of a randomized controlled trial to assess if How2trak can improve patients' experience, and detection of surgical site infections after colorectal surgery while reducing their risk of COVID-19 exposure. Methods: In this single-center, prospective feasibility trial, eligible patients undergoing elective and semi-urgent colorectal surgery will be randomized to either standard care or How2trak post-operative 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 meet virtually with the patient as needed. The primary outcome is feasibility as measured by enrollment, randomization, H2T usability, data extraction, and resource capacity. Results: We anticipate this work will help us to better understand the feasibility of using mobile technology to optimize patients' care after discharge from hospital after colorectal surgery. Virtual post-surgery wound and symptom monitoring could enhance patient experience, SSI detection, and reduce the risk of COVID-19 transmission. If this technology is feasible for our patient population and workflow, next steps will be to assess its effectiveness with a full-scale randomized controlled trial and explore additional applications including ostomy monitoring, patient education, and application in other surgical departments.

Conditions

• Surgical Site Infection
• Mobile Applications
• Surgery--Complications
• Colorectal Surgery

Interventions

Type	Name	Description
DEVICE	How2Trak mobile application	Patients will undergo virtual monitoring of their incision and symptoms using the How2Trak application(app). Using the app, patients will be asked to answer a series of questions and photograph their surgical incision on post-operative day 3, 5, 7, 10, 20, and 30. Patient responses and photographs entered into the app will be reviewed within 72 hours by a trained Nurse Specialized in Wound, Ostomy and Continence. If a concern is identified the nurse will contact the patient to arrange a virtual visit using the how2trak app or notify the surgeon team (including colorectal surgeons and physician residents) in accordance with clinical discretion.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-11-01
• Completion: 2022-02-01
• First posted: 2021-05-03
• Last updated: 2021-05-03