Multicenter Study Protocol: Research on Evaluation and Detection of Surgical Wound Complications with AI-based Recognition. (REDSCAR-trial)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RedScar App.
- Who it may be relevant to
- Registry conditions: Surgical Wound Infection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multicenter Study Protocol: Research on Evaluation and Detec-tion of Surgical Wound Complications with AI-based Recogni-tion. (REDSCAR-trial)
Overview
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
- Device 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.
Primary outcome measures
- Efficacy of RedScar App [Time frame: "From enrollment to the end of treatment at 8 weeks"]
Secondary outcome measures (1)
- Satisfaction Asessment [Time frame: From enrollment to the end of treatment at 8 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Diagnostic
Study locations
Spain · 5 centers
- Hospital de Fuenlabrada — Madrid
- Hospital Universitario Severo Ochoa — Madrid
- Hospital General Mateu Orfila — Mahón
- Hospital Universitario Son Espases — Palma
- Universidad Islas Baleares — Palma
Publications
- 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. PMID 39768786
- 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. PMID 28794868
Identifiers
NCT: NCT06771726 · IB 5087/22 PI · PID2020-113870GB-I00