Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
Universitat de les Illes Balears
168 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
The increasing use of telemedicine in surgical care has demonstrated significant poten-tial for improving patient outcomes and optimizing healthcare resources. This study investigates the efficacy of the RedScar© app in telematic detection and monitoring of surgical site infections (SSIs), a major cause of healthcare-associated infections (HAIs) with significant economic and health impacts. RedScar© leverages a patient's smartphone to provide automated infection risk assessments without requiring clini-cian input, offering a potential solution for remote postoperative care. In a pilot study, RedScar© demonstrated 100% sensitivity and 83.13% specificity in detecting SSIs, with high patient satisfaction regarding its comfort, cost-effectiveness, and ability to reduce absenteeism. This multicenter prospective study aims to validate these findings, com-paring app-based detection with in-person evaluations. Primary objectives include as-sessing the sensitivity and specificity of RedScar© using receiver operating character-istic (ROC) analysis, while secondary objectives include evaluating patient satisfaction and standardizing telematic follow-up across centers. The study will include 168 pa-tients undergoing abdominal surgery, with follow-up assessments conducted remotely via the app and in-person at specified intervals. Data will be analysed using descrip-tive and statistical methods to assess diagnostic accuracy and patient satisfaction. This research seeks to further develop RedScar© as a reliable, scalable tool for enhancing postoperative care, reducing healthcare costs, and improving patient experiences in surgical recovery.
Eligibility
Inclusion Criteria6
- Participants must have signed an informed consent.
- Participants must be over 18 years of age.
- Participants must have undergone either urgent or scheduled surgery performed via laparotomy or laparoscopy.
- Participants need access to a smartphone capable of downloading the app with android OS.
- Either the participant or a close family member must be able to operate the app effectively.
- Participants must be able to attend follow-up consultations at the surgical outpatient clinic after discharge, one week post-surgery, or earlier if the app flags a potential infection.
Exclusion Criteria4
- Patients who lack access to a smartphone or are unable to properly use the app.
- Patients unfamiliar with mobile devices or unable to comprehend the app's functionality or questions.
- Patients who did not provide informed consent.
- Patients who are unable to comply with the follow-up requirements.
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Interventions
use of the RedScar© app on patients' smartphones. Patients will complete a brief health questionnaire and upload a wound photograph to the app, which will provide recommendations based on the risk of infection detected. Simultaneously, an in-person wound assessment will be conducted by the investigator to compare results.
Locations(5)
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NCT06771726