Actively Recruiting
Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
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
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
Official Title
Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
Who Can Participate
Eligibility Criteria
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.
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
Complete this quick 3-step screening to check your eligibility
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
Research Team
A
Andrea Craus-Miguel, MD, cPhD
CONTACT
J
Juan José Segura-Sampedro, MD, PhD
CONTACT
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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