Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection

University of Sao Paulo

Status: Completed

Conditions: Surgical Wound Infection

Treatments: Device: VigiApp

Study type: Interventional

Funder types: Other

Identifiers

NCT05455710

Vigi-App

Details and patient eligibility

About

Objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision.

Full description

Introduction: Infection of the surgical site (SSI) is one of the main infections related to health care, culminating in financial losses to the health system and high morbidity and mortality, which due to increasingly shorter hospital stays, from 13 to 75% is manifested at home of the patient, requiring health professionals to act more effectively in post-discharge surveillance of this condition. Therefore, considering this problem and the constant evolution of technological resources, with the increase in access and use of smartphones by the population, it is pertinent to develop a mobile application for post-discharge surveillance of surgical site infection. Objective: evaluate the effectiveness and usability of a mobile application for post-discharge surveillance of surgical site infection as a support system for clinical decision. Method: Randomized Clinical Trial to assess effectiveness of a mobile application for post-discharge surveillance of infection of the surgical site. The study will be developed in a large hospital in the city of São Paulo and the study participants will be surgical patients. Expected results: The mobile application for post-discharge surveillance is expected to collaborate in the early detection of potential cases of surgical site infection, to be able to improve post-discharge surveillance strategies, assist in data management, decision making and actions to prevent infection of the surgical site.

Enrollment: 242 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• surgical patients aged 18 to 70 years
• conscious, oriented,
• literate
• have a smartphone compatible with the use of the application
• submitted to traditional anesthetic-surgical procedure
• classified as potentially contaminated
• experience the postoperative period at home

Exclusion criteria

• Patients with visual impairment
• physical restriction or communication problems
• undergoing surgery with implants
• videolaparoscopies or robotics sugery
• who already have the diagnosis of SSI at the time of discharge
• have been admitted to the Intensive Care Unit in the postoperative period

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

VigiApp

Experimental group

Description:

the intervention group, which will use the mobile application to detect SSI. The Vigi-App application will be installed on the Smartphone of the selected patients, who will receive training on how to use the application; should access it on days seven, 14, 21 and 30 after the surgical procedure, they will additionally be evaluated in person in an outpatient consultation, according to the hospital routine. The patients in the intervention group will receive notices the day before, through reminders issued by the application, reminding them that they must access and complete the requested information. If the patient presents signs and symptoms of infection on dates other than filling out the application, he can access the application and send his data normally as an extra access.

Treatment:

Device: VigiApp

telephone call

Sham Comparator group

Description:

the called control, consisting of the standard infection surgical site post-discharge surveillance the developed infection of the surgical site procedure, by means of a telephone call. You will receive guidance on phone calls; will follow the standard SSI post-discharge surveillance procedure, by means of a telephone call on days seven, 14, 21 and 30 after the date of surgery, being asked about the presence of signs and symptoms of infection according to the instrument previously validated in previous investigation and will be evaluated in person in an outpatient consultation, according to the hospital routine.

Treatment:

Device: VigiApp