Clinical trial NCT05485233: Redscar © Application for Detection of Infected Surgical Wounds
Official title: Evaluation of Redscar © Application for Detection and Monitoring Potentially Infected Surgical Wounds: a Quasy-experimental Study Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgical Wound Infection
Surgical Wound
Surgical Site Infection
Keywords: Surgical wound infection
Telematic follow-up
i-health
Lead sponsor: Hospital Son Espases
Sponsor class: OTHER
Collaborators: name: University of the Balearic Islands
name: Fundació d'investigació Sanitària de les Illes Balears
First posted: 2022-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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/.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity of RedScar© application to detect surgical infection compared to the face-to-face review.
timeFrame: 1 month
measure: Number of participants with related adverse events as assessed by CTCAE v4.0
timeFrame: 1 month
Secondary outcomes:
measure: Evaluate the satisfaction of the patients with the telematic care with the RedScar© app.
timeFrame: 1 month
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: University Hospital Son Espases
Study officials:
affiliation: Son Espases University Hospital
name: Juan José Segura-Sampedro
role: PRINCIPAL_INVESTIGATOR
References:
citation: Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK536404/
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 and Biomechanics. 2019. p. 219-29. Available from: http://link.springer.com/10.1007/978-3-030-32040-9_23
citation: 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-annual-1
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. doi: 10.1258/135763303321159693.
citation: 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.