Redscar © Application for Detection of Infected Surgical Wounds

Sponsor

Hospital Son Espases (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05485233

Collaborator

University of the Balearic Islands (Other), Fundació d'investigació Sanitària de les Illes Balears (Other)

Enrollment

Location

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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/.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Infection Surgical Wound Surgical Site Infection	Device: REDSCAR App

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

30 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Evaluation of Redscar © Application for Detection and Monitoring Potentially Infected Surgical Wounds: a Quasy-experimental Study Protocol

Actual Study Start Date :

May 1, 2020

Actual Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Presencial At day 3th and 10th after surgery, each patient will undergo face-to-face examination of their surgical wound by a physician or a nurse, who will confirme the presence or absence of complications and they will fill in the questionnarie to compare the reponses with the aplication
Telematic 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.	Device: REDSCAR App Patients will be discharged after surgery at the time it is considered by the responsible physician. Prior to discharge, patients taking part in the study will follow the same protocol as any other patient treated in our institution. Written consent will be signed after complete explanation of the study protocol by the researcher at this moment. The patient will download the RedScar© application and the researcher will explain how it works and how to answer all the questions about the wound (redness, pain). 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.

Arm

Intervention/Treatment

Presencial

At day 3th and 10th after surgery, each patient will undergo face-to-face examination of their surgical wound by a physician or a nurse, who will confirme the presence or absence of complications and they will fill in the questionnarie to compare the reponses with the aplication

Telematic

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.

Device: REDSCAR App

Patients will be discharged after surgery at the time it is considered by the responsible physician. Prior to discharge, patients taking part in the study will follow the same protocol as any other patient treated in our institution. Written consent will be signed after complete explanation of the study protocol by the researcher at this moment. The patient will download the RedScar© application and the researcher will explain how it works and how to answer all the questions about the wound (redness, pain). 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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.