Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
Trial ID: NCT06771726
Status: RECRUITING
Study type: INTERVENTIONAL
Phase: PHASE2; PHASE3
Start date: 2024-01-01
Completion date: 2025-12
Sponsor: Universitat de les Illes Balears
Conditions: Surgical Wound Infection
Interventions: RedScar App
Locations: Hospital de Fuenlabrada; Hospital Universitario Severo Ochoa; Hospital General Mateu Orfila; Hospital Universitario Son Espases; Universidad Islas Baleares
Countries: Spain; Spain; Spain; Spain; Spain
Enrollment: 168
Age range: 18 Years - None
Sex: ALL

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.

Eligibility criteria:
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.

Outcomes:
Efficacy of RedScar App