Redscar © Application for Detection of Infected Surgical Wounds
- Conditions
- Surgical Wound InfectionSurgical WoundSurgical Site Infection
- Interventions
- Device: REDSCAR App
- Registration Number
- NCT05485233
- Lead Sponsor
- Hospital Son Espases
- Brief Summary
Surgical site infection (SSI) is the second cause of healthcare-associated infections (HAIs). Its appearance increase mobidity and post-operatice hospital stays, increasing costs aswell, although its one of the most preventable HAI.
The diagnosis and detection of SSI is usually carried out late by non-especialists once the patient has consulted to the emergency services or primary care with an already obvious infections. This raise both the direct and indirect costs and saturaties the emergency department and primary care, while delays treatment and increase disconfort and morbidity.
A smart phone aplication (RedScar© ) was developped in order to detect and monitor wound infection remotely based on an automated algorithm with no medical intervention.This app allows the patient to upload a photography and answer a short questionary, the aplication will then give a diagnosis of possible infection and recommendations.
This study is the first one to use a smartphone-based automatic aplication on real patients to diagnosis wound infection . This is a prospective, single-institution not randomized quasy-experimental study protocol. The study design and protocol were reviewed and approved by Research Ethics Committee of the Balearic Islands (CEI-IB).
This paper is part of the R+D+i Project PID2020-113870GB-I00- "Desarrollo de herramientas de Soft Computing para la Ayuda al Diagnóstico Clínico y a la Gestión de Emergencias (HESOCODICE)", funded by MCIN/AEI/10.13039/501100011033/.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- Signature of written consent.
- Age over 18 years.
- Emergency and scheduled surgery inpatients who have undergone abdominal surgery using staples to close the wound.
- Access to an android-based smartphone device, able to download the app and understand its management.
- Possibility of in person revision on the tenth postoperative day. Exclusion criteria
- Patients who do not have access to a compatible Smartphone or who are not able to use the app correctly (not being familiar with mobile devices or inability to understand how the app works or the questions asked).
- No written consent.
- Impossibility of personal revision.
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Telematic REDSCAR App At day 3th and 10th after surgery, each patient will upload an image of the surgical wound via RedScar© aplication using their own smartphone device. RedScar© aplication will evaluate the risk of complications of the surgical wound and will assign patients to 2 different groups: potential complications requiring new consultation or satisfactory evolution and discharge.
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of RedScar© application to detect surgical infection compared to the face-to-face review. 1 month Receiver operating characteristic (ROC) curve analysis will be used to identify the optimal cut-off value of Red Proportion in surgical infection screening with maximum sensitivity and specificity.
Number of participants with related adverse events as assessed by CTCAE v4.0 1 month
- Secondary Outcome Measures
Name Time Method Evaluate the satisfaction of the patients with the telematic care with the RedScar© app. 1 month e satisfaction of the patients with the telematic care with the RedScar© app through the Telemedicine Satisfaction Questionnaire developed and validated by Yip MP et al. and on similar studies
Trial Locations
- Locations (1)
University Hospital Son Espases
🇪🇸Palma De Mallorca, Spain