Redscar © Application for Detection of Infected Surgical Wounds

July 31, 2022 updated by: Juan José Segura, Hospital Son Espases

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

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/.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Palma De Mallorca, Spain
        • University Hospital Son Espases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

A total of 30 emergency and scheduled surgery inpatients who are adults (over age 18 or with an authorization from mother/father/guardian) and have undergone abdominal laparotomy closed with staples will be screened for eligibility. Potentially eligible patients will be selected and documented as included, missed, rejected or excluded. Written consent will be obtained by the research team.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of RedScar© application to detect surgical infection compared to the face-to-face review.
Time Frame: 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.
1 month
Number of participants with related adverse events as assessed by CTCAE v4.0
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the satisfaction of the patients with the telematic care with the RedScar© app.
Time Frame: 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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Espases

Collaborators

Fundació d'investigació Sanitària de les Illes Balears
University of the Balearic Islands

Investigators

  • Principal Investigator: Juan José Segura-Sampedro, Son Espases University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2020

Primary Completion (Actual)

September 1, 2021

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

July 1, 2022

First Submitted That Met QC Criteria

July 31, 2022

First Posted (Actual)

August 3, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

July 31, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB4100/20 PI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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