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

Phase 2

Recruiting

• Conditions: Surgical Wound Infection

• Registration Number: NCT06771726
• Lead Sponsor: Universitat de les Illes Balears

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2025-01
• Study First Submitted: 2025-01-07
• Study First Submitted QC: 2025-01-07
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 168

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Efficacy of RedScar App	"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 Outcome Measures

Name	Time	Method
Satisfaction Asessment	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.

Trial Locations

Locations (5)

Hospital de Fuenlabrada; 🇪🇸 Madrid, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Madrid, Spain

Hospital General Mateu Orfila; 🇪🇸 Mahón, Spain

Hospital Universitario Son Espases; 🇪🇸 Palma, Spain

Universidad Islas Baleares; 🇪🇸 Palma, Spain