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

NCT05455710 | Completed

• 1 other identifier: Vigi-App
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Surgical Wound Infection

Keywords

Mobile applications; Patient discharge; Surgical wound infection; Public health surveillance; Perioperative nursing.

Outcome Measures

Primary Outcomes (2)

• effectiveness of the mobile app - sensitivity

  The effectiveness of the integrated mobile application for the SSI post-discharge surveillance in the correct and early identification of the SSI, through measures of sensitivity in percentage.

  Four months

• effectiveness of the mobile app - specificity

  The effectiveness of the integrated mobile application for the SSI post-discharge surveillance in the correct and early identification of the SSI, through measures of specificity in percentage.

  Four months

Secondary Outcomes (2)

• rate of adherence

  Four months

• usability and user satisfaction

  Four months

Study Arms (2)

VigiApp

EXPERIMENTAL

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.

Device: VigiApp

telephone call

SHAM COMPARATOR

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.

Device: VigiApp

Interventions

VigiApp DEVICE

mobile application containing a patient identification module; post-discharge surveillance questionnaire with questions related to signs and symptoms of SSI previously validated; possibility of attaching and sending a photograph of the surgical wound; field for exchanging messages between professional and patient; issuing an alert / reminder to fill in the data in the application; in addition to establishing interoperability with the system used by the hospital's SCIH, containing a login for each health professional, which allows access to the answers, images and messages sent by surgical patients, categorizing risk and issuing alerts in suspected cases of SSI.

VigiApp; telephone call

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (2)

Hospital Universitário UFSC

Florianópolis, Brazil

Location

ICESP

São Paulo, Brazil

Location

Related Publications (4)

• Wiseman JT, Fernandes-Taylor S, Barnes ML, Tomsejova A, Saunders RS, Kent KC. Conceptualizing smartphone use in outpatient wound assessment: patients' and caregivers' willingness to use technology. J Surg Res. 2015 Sep;198(1):245-51. doi: 10.1016/j.jss.2015.05.011. Epub 2015 May 14.

  PMID: 26025626 BACKGROUND

• Sanger PC, Hartzler A, Han SM, Armstrong CA, Stewart MR, Lordon RJ, Lober WB, Evans HL. Patient perspectives on post-discharge surgical site infections: towards a patient-centered mobile health solution. PLoS One. 2014 Dec 1;9(12):e114016. doi: 10.1371/journal.pone.0114016. eCollection 2014.

  PMID: 25436912 BACKGROUND

• Gunter RL, Fernandes-Taylor S, Rahman S, Awoyinka L, Bennett KM, Weber SM, Greenberg CC, Kent KC. Feasibility of an Image-Based Mobile Health Protocol for Postoperative Wound Monitoring. J Am Coll Surg. 2018 Mar;226(3):277-286. doi: 10.1016/j.jamcollsurg.2017.12.013. Epub 2018 Jan 19.

  PMID: 29366555 BACKGROUND

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Vanessa Poveda, doutorate

  USP

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: In order to verify the effectiveness of the mobile application for post-discharge surveillance the developed infection of the surgical site, a randomized clinical trial of superiority will be carried out.

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: July 13, 2022
• Study Start: March 6, 2023
• Primary Completion: November 8, 2024
• Study Completion: November 8, 2024
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)