Surgical Wound Infection
Conditions
Keywords
surgical wound infection, Telemedicine, smartphone application, artificial intelligence
Brief 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.
Interventions
DEVICERedScar App
use of the RedScar© app on patients' smartphones. Patients will complete a brief health questionnaire and upload a wound photograph to the app, which will provide recommendations based on the risk of infection detected. Simultaneously, an in-person wound assessment will be conducted by the investigator to compare results.
Sponsors
Universitat de les Illes Balears
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
This multicenter prospective study uses a paired cohort design with a non-randomized, single-blinded approach, where each participant served as their own control. The investigators remain unaware of the application's recommendations dur-ing wound assessments. The study will include adult patients undergoing abdominal surgery at different hospitals. This study involves the use of the RedScar© app on pa-tients' smartphones. Patients will complete a brief health questionnaire and upload a wound photograph to the app, which will provide recommendations based on the risk of infection detected. Simultaneously, an in-person wound assessment will be con-ducted by the investigator to compare results.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of RedScar App | From enrollment to the end of treatment at 8 weeks | To assess the sensitivity and specificity of the RedScar© application for detecting wound infection, comparing the app with in-person diagnosis. The ROC curve will be used to analyze the overall performance of the app and identify the optimal cut-off for the Red Proportion (maximizing sensitivity and specificity). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction Asessment | From enrollment to the end of treatment at 8 weeks | Assess the satisfaction level of subjects undergoing telemedicine-based follow-up using a validated telemedicine satisfaction questionnaire (Yip et al.). Minimum: 0. Maximum: 14. Higher scores mean a better satisfaction. |
Countries
Spain
Contacts
Primary ContactAndrea Craus-Miguel, MD, cPhD
Backup ContactJuan José Segura-Sampedro, MD, PhD
Outcome results
None listed