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

NCT06771726 | Recruiting Phase 2

• 2 other identifiers: IB 5087/22 PIPID2020-113870GB-I00
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Surgical Wound Infection

Keywords

surgical wound infection; Telemedicine; smartphone application; artificial intelligence

Outcome Measures

Primary Outcomes (1)

• Efficacy of RedScar App

  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).

  "From enrollment to the end of treatment at 8 weeks"

Secondary Outcomes (1)

• Satisfaction Asessment

  From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Redscar app

EXPERIMENTAL

Telematic follow-up with App

Device: RedScar App

In-Person

NO INTERVENTION

In-person visit to the clinics

Interventions

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.

Redscar app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat de les Illes Balears: lead

Study Sites (5)

Hospital de Fuenlabrada

Madrid, Spain

COMPLETED

Hospital Universitario Severo Ochoa

Madrid, Spain

RECRUITING

Hospital General Mateu Orfila

Maó, Spain

RECRUITING

Hospital Universitario Son Espases

Palma, Spain

COMPLETED

Universidad Islas Baleares

Palma, Spain

COMPLETED

Related Publications (2)

• Craus-Miguel A, Munar M, Moya-Alcover G, Contreras-Nogales AM, Gonzalez-Hidalgo M, Segura-Sampedro JJ. Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections. J Clin Med. 2024 Dec 23;13(24):7863. doi: 10.3390/jcm13247863.

  PMID: 39768786 BACKGROUND

• Segura-Sampedro JJ, Rivero-Belenchon I, Pino-Diaz V, Rodriguez Sanchez MC, Pareja-Ciuro F, Padillo-Ruiz J, Jimenez-Rodriguez RM. Feasibility and safety of surgical wound remote follow-up by smart phone in appendectomy: A pilot study. Ann Med Surg (Lond). 2017 Jul 18;21:58-62. doi: 10.1016/j.amsu.2017.07.040. eCollection 2017 Sep.

  PMID: 28794868 BACKGROUND

Related Links

• RedScar Image Repository

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrea Craus-Miguel, MD, cPhD

CONTACT

0034 661115968; acrausm@gmail.com

Juan José Segura-Sampedro, MD, PhD

CONTACT

0034 637028024; juanjose.segura@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This multicenter prospective study uses a paired cohort design with a non-randomized, single-blinded approach, where each participant served as their own control. The investigators remain unaware of the application's recommendations dur-ing wound assessments. The study will include adult patients undergoing abdominal surgery at different hospitals. This study involves the use of the RedScar© app on pa-tients' 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 con-ducted by the investigator to compare results.

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: January 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 2023-No limit
• Access Criteria: Authorization must be granted via email.

Locations

ES (5)