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

Recruiting now · Phase 2/Phase 3

Conditions studied: Surgical Wound Infection

In brief

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.

Key facts

Study ID

NCT06771726

Run by

Universitat de les Illes Balears

People needed

168

Starts

2024-01-01

Expected to finish

2025-12-01

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Hospital Universitario Severo Ochoa — Madrid, Spain (enrolling)
• Hospital General Mateu Orfila — Mahón, Spain (enrolling)
• Hospital de Fuenlabrada — Madrid, Spain
• Hospital Universitario Son Espases — Palma, Spain
• Universidad Islas Baleares — Palma, Spain

Full record on ClinicalTrials.gov

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