Clinical trial NCT06771726: Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
Official title: Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Surgical Wound Infection
Keywords: surgical wound infection
Telemedicine
smartphone application
artificial intelligence
Lead sponsor: Universitat de les Illes Balears
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of RedScar App
timeFrame: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes:
measure: Satisfaction Asessment
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital de Fuenlabrada
city: Madrid
country: Spain
facility: Hospital Universitario Severo Ochoa
city: Mahón
country: Spain
facility: Hospital General Mateu Orfila
city: Palma
country: Spain
facility: Hospital Universitario Son Espases
city: Palma
country: Spain
facility: Universidad Islas Baleares
Study officials:
References:
citation: Craus-Miguel A, Munar M, Moya-Alcover G, Contreras-Nogales AM, Gonzalez-Hidalgo M, Segura-Sampedro JJ. Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections. J Clin Med. 2024 Dec 23;13(24):7863. doi: 10.3390/jcm13247863.
citation: Segura-Sampedro JJ, Rivero-Belenchon I, Pino-Diaz V, Rodriguez Sanchez MC, Pareja-Ciuro F, Padillo-Ruiz J, Jimenez-Rodriguez RM. Feasibility and safety of surgical wound remote follow-up by smart phone in appendectomy: A pilot study. Ann Med Surg (Lond). 2017 Jul 18;21:58-62. doi: 10.1016/j.amsu.2017.07.040. eCollection 2017 Sep.