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

Last updated: January 16, 2025
Sponsor: Universitat de les Illes Balears
Overall Status: Active - Recruiting

Phase

2/3

Condition

Pressure Ulcer

Treatment

RedScar App

Clinical Study ID

NCT06771726
IB 5087/22 PI
PID2020-113870GB-I00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 vialaparotomy or laparoscopy.

  • Participants need access to a smartphone capable of downloading the app with androidOS.

  • Either the participant or a close family member must be able to operate the appeffectively.

  • Participants must be able to attend follow-up consultations at the surgicaloutpatient clinic after discharge, one week post-surgery, or earlier if the appflags a potential infection.

Exclusion

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'sfunctionality or questions.

  • Patients who did not provide informed consent.

  • Patients who are unable to comply with the follow-up requirements.

Study Design

Total Participants: 168
Treatment Group(s): 1
Primary Treatment: RedScar App
Phase: 2/3
Study Start date:
January 01, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Hospital Universitario Severo Ochoa

    Madrid,
    Spain

    Active - Recruiting

  • Hospital de Fuenlabrada

    Madrid,
    Spain

    Completed

  • Hospital General Mateu Orfila

    Mahón,
    Spain

    Active - Recruiting

  • Hospital General Mateu Orfila

    Menorca,
    Spain

    Site Not Available

  • Hospital Universitario Son Espases

    Palma,
    Spain

    Completed

  • Universidad Islas Baleares

    Palma,
    Spain

    Completed

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