Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)

Condition(s) studied

Investigational drug(s) / intervention(s)

RedScar 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.

Study 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

Primary outcome measure(s)

• 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).

Trial sites (5)

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