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Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllUniversitat de les Illes Balears
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In plain words

What the trial is, and whether it could suit you

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-pers

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • RedScar App
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Where

5 sites
Hospital de Fuenlabrada
Madrid, Spain
Hospital Universitario Severo Ochoa
Madrid, Spain
Hospital General Mateu Orfila
Mahón, Spain
Hospital Universitario Son Espases
Palma, Spain
Universidad Islas Baleares
Palma, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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