Redscar © Application for Detection of Infected Surgical Wounds

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05485233
• Other study ID #: IB4100/20 PI
• Status: Enrolling by invitation
• Start date: May 1, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2022
• Source: Hospital Son Espases
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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/.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: January 1, 2023
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Surgical Site Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Spain	University Hospital Son Espases	Palma De Mallorca

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Son Espases	Fundació d'investigació Sanitària de les Illes Balears, University of the Balearic Islands

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. — View Citation

González-Hidalgo M, Moyà-Alcover G, Munar M, Bibiloni P, Craus-Miguel A, González-Argenté X, et al. Detection and Automatic Deletion of Staples in Images of Wound of Abdominal Surgery for m-Health Applications. In: Lecture Notes in Computational Vision an

Healthcare-associated infections: surgical site infections - Annual Epidemiological Report for 2017 [Internet]. [cited 2022 Feb 27]. Available from: https://www.ecdc.europa.eu/en/publications-data/healthcare-associated-infections-surgical-site-infections-

Segura-Sampedro JJ, Rivero-Belenchón I, Pino-Díaz V, Rodríguez Sánchez MC, Pareja-Ciuró 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). — View Citation

Yip MP, Chang AM, Chan J, MacKenzie AE. Development of the Telemedicine Satisfaction Questionnaire to evaluate patient satisfaction with telemedicine: a preliminary study. J Telemed Telecare. 2003;9(1):46-50. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of RedScar© application to detect surgical infection compared to the face-to-face review.	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
Primary	Number of participants with related adverse events as assessed by CTCAE v4.0		1 month
Secondary	Evaluate the satisfaction of the patients with the telematic care with the RedScar© app.	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

External Links

•   Healthcare-associated infections: surgical site infections - Annual Epidemiological Report for 2017