Actively Recruiting

Phase 2
Phase 3
Age: 18Years +
All Genders
ID06771726

Multicenter Study on Using the RedScar App for Detecting Surgical Wound Infections Compared with In-Person Assessments

Led by Universitat de les Illes Balears · Updated on 2025-01-20

168

Participants Needed

5

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the use of the RedScar© app to detect and monitor surgical site infections (SSIs), which are common and costly healthcare-associated infections. This multicenter, prospective study aims to validate the app's accuracy in identifying infections after abdominal surgery by comparing its assessments with in-person evaluations. The study also seeks to evaluate patient satisfaction and create a standard telemedicine follow-up process across different centers. The study involves patients who have undergone urgent or scheduled laparotomy or laparoscopy surgeries. Participants will use the RedScar© app on their smartphones, where they complete a short health questionnaire and upload a wound photograph. The app then provides recommendations based on infection risk without clinician input. At the same time, investigators will perform physical wound assessments to compare results. Follow-up visits are planned one week after surgery or earlier if the app detects a possible infection. Participants will be monitored from enrollment until the end of treatment at 8 weeks. During this period, researchers will collect data on the app's diagnostic accuracy, including sensitivity and specificity, through statistical analysis. Patient satisfaction with the app's usability and benefits will also be assessed. The study aims to improve postoperative care by offering a reliable and scalable remote monitoring tool that may reduce healthcare costs and improve patient experiences.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants must have signed an informed consent.
  • Participants must be over 18 years of age.
  • Participants must have undergone urgent or scheduled abdominal surgery via laparotomy or laparoscopy.
  • Participants need access to a smartphone with Android OS.
  • Participant or a close family member must be able to use 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 flagged by the app.
Not Eligible

You will not qualify if you...

  • Patients without access to a smartphone or unable to use the app.
  • Patients unfamiliar with mobile devices or unable to understand the app's questions.
  • Patients who did not provide informed consent.
  • Patients unable to comply with follow-up requirements.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 5 locations

1

Hospital de Fuenlabrada

Madrid, Spain

Completed

2

Hospital Universitario Severo Ochoa

Madrid, Spain

Actively Recruiting

3

Hospital General Mateu Orfila

Mahón, Spain

Actively Recruiting

4

Hospital Universitario Son Espases

Palma, Spain

Completed

5

Universidad Islas Baleares

Palma, Spain

Completed

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Research Team

A

Andrea Craus-Miguel, MD, cPhD

J

Juan José Segura-Sampedro, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections.

Andrea Craus-Miguel, Marc Munar, Gabriel Moyà-Alcover...

https://pubmed.ncbi.nlm.nih.gov/39768786

Feasibility and safety of surgical wound remote follow-up by smart phone in appendectomy: A pilot study.

Juan José Segura-Sampedro, Inés Rivero-Belenchón, Verónica Pino-Díaz...

https://pubmed.ncbi.nlm.nih.gov/28794868