EICHORCondition: Surgical Wound Infection · Sponsor: Universitat de les Illes Balears
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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 R…
This description comes directly from the study's public registry record.
Andrea Craus-Miguel, MD, cPhD · 0034 661115968 · acrausm@gmail.com
Juan José Segura-Sampedro, MD, PhD · 0034 637028024 · juanjose.segura@salud.madrid.org
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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.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Hospital de Fuenlabrada | Madrid, Spain | Completed |
| Hospital Universitario Severo Ochoa | Madrid, Spain | Recruiting |
| Hospital General Mateu Orfila | Mahón, Spain | Recruiting |
| Hospital Universitario Son Espases | Palma, Spain | Completed |
| Universidad Islas Baleares | Palma, Spain | Completed |
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Source record: clinicaltrials.gov/study/NCT06771726