Using an app to detect surgical wound infections
Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
This study is testing a smartphone app that helps patients check for surgical wound infections after surgery to see if it works better than regular doctor visits.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat de les Illes Balears Academic / other |
| Locations | 5 sites (Madrid and 4 other locations) |
| Trial ID | NCT06771726 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the RedScar© app in monitoring and detecting surgical site infections (SSIs) through telemedicine. By utilizing a patient's smartphone, the app provides automated assessments of infection risk without needing clinician input, aiming to enhance postoperative care. The multicenter study will compare the app's detection capabilities against traditional in-person evaluations, focusing on its sensitivity and specificity. Previous pilot studies have shown promising results, indicating high patient satisfaction and potential for reducing healthcare costs.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 who have undergone laparotomy or laparoscopy and have access to a compatible smartphone.
Not a fit: Patients without access to a smartphone or those unable to use the app effectively may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the detection and management of surgical wound infections, leading to better patient outcomes and reduced healthcare costs.
How similar studies have performed: Previous studies have shown success with similar telemedicine approaches in surgical care, indicating a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Madrid and 4 other locations
- Hospital de Fuenlabrada — Madrid, Spain (Completed)
- Hospital Universitario Severo Ochoa — Madrid, Spain (Recruiting)
- Hospital General Mateu Orfila — Mahón, Spain (Recruiting)
- Hospital Universitario Son Espases — Palma, Spain (Completed)
- Universidad Islas Baleares — Palma, Spain (Completed)
Study contacts
- Study coordinator: Andrea Craus-Miguel, MD, cPhD
- Email: acrausm@gmail.com
- Phone: 0034 661115968
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.