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

Surgical Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05455710
• Other study ID #: Vigi-App
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University of Sao Paulo
• Contact: Camila Dalcól, doutorate
• Phone: +5543999856389
• Email: camiladalcol[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Wound
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• VigiApp
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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário UFSC	Florianopolis
Brazil	ICESP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Four months
Secondary	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.	Four months