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Surgical Wound InfectionNCT05455710

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

A study testing VigiApp in people with Surgical Wound Infection, run by University of Sao Paulo at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Surgical Wound Infection
What is being tested?
VigiApp
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
242 participants
Where
2 sitesBrazil
Study dates
6 Mar 2023to 8 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Hospital Universitário UFSC

    Florianópolis

  • ICESP

    São Paulo

Other trials in Brazil

About this study

Official title: Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection as a Clinical Decision Support System

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.

Read the detailed 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.

Being tested
VigiApp
Keywords
Mobile applications, Patient discharge, Surgical wound infection, Public health surveillance, Perioperative nursing.
Medical subject headings
Surgical Wound Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VigiAppDevice

    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.

Study groups in NCT05455710
Study groupRoleWhat they receive
VigiAppExperimentalthe 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.
Receives: Device: VigiApp
telephone callSham comparatorthe 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.
Receives: Device: VigiApp

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Four months

  2. 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.

    Measured: Four months

Secondary outcomes (2)

  1. rate of adherence

    The rate of adherence will be verified, quantitatively, according to the number of patients accessing the application and according to the successful telephone contact of healthcare professionals with patients.

    Measured: Four months

  2. usability and user satisfaction

    To assess usability and user satisfaction, the Measurement Inventory Usability Software will be used, in likert (agree and disagree), which 50 items, with user satisfaction in use in five usability dimensions: efficiency, satisfaction, usefulness , control and learning, each with 10 items.

    Measured: Four months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2022
  2. Study start6 Mar 2023
  3. Primary completion8 Nov 2024
  4. Study completion8 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
242 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05455710
Sponsor's protocol ID
Vigi-App
Status last verified
Jul 2025
First submitted
9 Oct 2020
Last updated
18 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26025626

  • 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.

    PubMed 25436912

  • 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.

    PubMed 29366555

  • 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.

    PubMed 23295957

Questions about this trial

What is this clinical trial studying?

A study testing VigiApp in people with Surgical Wound Infection, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

effectiveness of the mobile app - sensitivity (time frame: Four months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05455710, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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