Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06771726

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hospital Universitario Severo Ochoa, Madrid, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RedScar App

Device

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.

Primary outcomes

  1. Efficacy of RedScar App

    Time frame: "From enrollment to the end of treatment at 8 weeks"

    To assess the sensitivity and specificity of the RedScar© application for detecting wound infection, comparing the app with in-person diagnosis. The ROC curve will be used to analyze the overall performance of the app and identify the optimal cut-off for the "Red Proportion" (maximizing sensitivity and specificity).

Secondary outcomes

  1. Satisfaction Asessment

    Time frame: From enrollment to the end of treatment at 8 weeks

    Assess the satisfaction level of subjects undergoing telemedicine-based follow-up using a validated telemedicine satisfaction questionnaire (Yip et al.). Minimum: 0. Maximum: 14. Higher scores mean a better satisfaction.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Craus-Miguel, MD, cPhD

CONTACT

[email protected]

0034 661115968

Juan José Segura-Sampedro, MD, PhD

CONTACT

[email protected]

0034 637028024

Sponsors and collaborators

Lead sponsor

Universitat de les Illes Balears

Other

Registry information

Official study title

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

Acronym: REDSCAR

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 13, 2025
Registry last updated
Jan 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.