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Surgical Wound InfectionNCT05485233

Redscar © Application for Detection of Infected Surgical Wounds

An observational study of Surgical Wound Infection and Surgical Wound, run by Hospital Son Espases at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REDSCAR App
Type of treatment
Medical device
How many people
30 participants
Where
1 siteSpain
Study dates
1 May 2020to 1 Jan 2023
How long will I take part?
1 Month
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • University Hospital Son Espases

    Palma de Mallorca

Other trials in Spain

About this study

Official title: 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.

Read more

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/.

Being tested
REDSCAR App
Keywords
Surgical wound infection, Telematic follow-up, i-health
Medical subject headings
Surgical Wound Infection, Surgical Wound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REDSCAR AppDevice

    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.

Study groups in NCT05485233
Study groupRoleWhat they receive
PresencialAt 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
TelematicAt 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.
Receives: Device: REDSCAR App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 1 month

  2. Number of participants with related adverse events as assessed by CTCAE v4.0

    Measured: 1 month

Secondary outcomes (1)

  1. 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

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start1 May 2020
  3. Primary completion1 Sep 2021
  4. Study completion1 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
30 participants (estimated)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT05485233
Sponsor's protocol ID
IB4100/20 PI
Status last verified
Jul 2022
First submitted
1 Jul 2022
Last updated
3 Aug 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Global Guidelines for the Prevention of Surgical Site Infection. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK536404/

    PubMed 30689333

  • 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

  • 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

  • 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.

    PubMed 12641893

  • 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.

    PubMed 28794868

  • Craus-Miguel A, Munar M, Moya-Alcover G, Contreras-Nogales AM, Gonzalez-Hidalgo M, Segura-Sampedro JJ. Enhancing Surgical Wound Monitoring: A Paired Cohort Study Evaluating a New AI-Based Application for Automatic Detection of Potential Infections. J Clin Med. 2024 Dec 23;13(24):7863. doi: 10.3390/jcm13247863.

    PubMed 39768786

Questions about this trial

What is this clinical trial studying?

An observational study of Surgical Wound Infection and Surgical Wound, run by Hospital Son Espases at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and specificity of RedScar© application to detect surgical infection compared to the face-to-face review. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05485233, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.

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