Clinical trial NCT05455710: Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection
Official title: Evaluation of Post-discharge Surveillance Mobile Application for Surgical Site Infection as a Clinical Decision Support System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Wound Infection
Keywords: Mobile applications
Patient discharge
Surgical wound infection
Public health surveillance
Perioperative nursing.
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: effectiveness of the mobile app - sensitivity
timeFrame: Four months
measure: effectiveness of the mobile app - specificity
timeFrame: Four months
Secondary outcomes:
measure: rate of adherence
timeFrame: Four months
measure: usability and user satisfaction
timeFrame: Four months
Other outcomes:
Locations:
city: Florianopolis
country: Brazil
facility: Hospital Universitário UFSC
city: São Paulo
country: Brazil
facility: ICESP
Study officials:
affiliation: USP
name: Vanessa Poveda, doutorate
role: STUDY_DIRECTOR
References:
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.
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.
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.
citation: 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.