Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections.
Andrea Craus-Miguel, Marc Munar, Gabriel Moyà-Alcover...
https://pubmed.ncbi.nlm.nih.gov/39768786Actively Recruiting
Phase 2
Phase 3
Age: 18Years +
All Genders
ID06771726
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of the RedScar app in detecting and monitoring surgical site infections (SSIs) after abdominal surgery. SSIs are a common healthcare-associated infection with significant health and economic impacts. The study is a multicenter, prospective trial designed to validate the app's performance compared to standard in-person evaluations. It seeks to improve postoperative care by providing automated infection risk assessments via patients' smartphones without needing clinician input. Participants will be divided into two groups: one using the RedScar app for telematic follow-up and the other attending traditional in-person clinic visits. Patients using the app will complete a brief health questionnaire and upload photos of their surgical wounds, which the app analyzes for infection risk. Both groups will be assessed at specified intervals, including an 8-week treatment period. The study also evaluates patient satisfaction and aims to standardize telematic follow-up across multiple centers. Throughout the study, participants will undergo follow-up consultations either remotely via the app or in-person at surgical outpatient clinics. Data collection includes wound photographs, health questionnaires, and infection assessments. Researchers will analyze diagnostic accuracy using statistical methods, focusing on sensitivity and specificity of the app's detection capabilities. Patient satisfaction and overall experience will also be measured, with all monitoring occurring from enrollment through 8 weeks post-treatment.
CONDITIONS
Brief Title
Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
Who Can Participate
Age: 18Years +
All Genders
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 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - Up to 8 weeks
Participants use the RedScar app on their smartphones to complete health questionnaires and upload wound photographs, while an in-person wound assessment is conducted by the investigator.
Telematic app use with follow-up visits at the surgical outpatient clinic, including at least 1 visit one week post-surgery or earlier if the app flags a potential infection
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
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Research Team
A
Andrea Craus-Miguel, MD, cPhD
J
Juan José Segura-Sampedro, MD, PhD
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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Published Research Related To This Trial
Feasibility and safety of surgical wound remote follow-up by smart phone in appendectomy: A pilot study.
Juan José Segura-Sampedro, Inés Rivero-Belenchón, Verónica Pino-Díaz...
https://pubmed.ncbi.nlm.nih.gov/28794868