Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial

NCT ID: NCT06586749

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-09-01

Brief Summary

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The goal of this clinical trial is to determine if nurse-led education and tele-interventions can reduce the incidence of surgical wound infections in patients after coronary artery bypass surgery. The main questions it aims to answer are:

* Can nurse-led education reduce the rate of surgical wound infections after coronary artery bypass surgery?
* Does the addition of tele-interventions further decrease the incidence of these infections compared to standard care?

Researchers will compare three groups:

* Group A: Standard postoperative care
* Group B: Nurse-led patient education
* Group C: Nurse-led patient education plus tele-interventions

Participants will:

* Receive standard care, nurse-led education, or nurse-led education with tele-interventions
* Having regular follow-up as per group assignment
* Monitor and report infection during the study period

Detailed Description

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Conditions

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Surgical Site Infection Coronary Artery Bypass Grafting (CABG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group: Group A

No education and implementation of teleinterventions, whereas implementation of standard care based on the existing protocol of the Clinical Department is going to be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B: nurse-led education

The participants in Group B will be guided and trained by the principal investigator based on a specially designed educational booklet. Group B will also receive teleinterventions.

Group Type EXPERIMENTAL

Group B: nurse-led education

Intervention Type OTHER

Group B: nurse-led education No educational video, will be shown to this group of patients

Group C: nurse-led education and implementation of teleinterventions

The participants in Group C will be guided and trained by the principal investigator based on a specially designed educational booklet. Group C will also receive teleinterventions and a guidance video will be presented to them

Group Type EXPERIMENTAL

Group C: nurse-led education and implementation of teleinterventions

Intervention Type OTHER

Group C: nurse-led education and implementation of teleinterventions An educational video, made for the purposes of the study only, will be shown to them. This is the difference between the two groups

Interventions

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Group B: nurse-led education

Group B: nurse-led education No educational video, will be shown to this group of patients

Intervention Type OTHER

Group C: nurse-led education and implementation of teleinterventions

Group C: nurse-led education and implementation of teleinterventions An educational video, made for the purposes of the study only, will be shown to them. This is the difference between the two groups

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Patients who have undergone CABG with median sternotomy
* Proficiency in reading and writing in Greek
* Patients who provide written informed consent for participation in the study
* Patients who have access to a mobile phone and know how to use it
* Patients without difficulties in vision, speech, or hearing
* Patients at intermediate or high risk for developing surgical site infections, based on their scores in the risk stratification models described below

Exclusion Criteria

* History of psychiatric illness, recent history of alcohol and/or substance abuse, dementia, and Alzheimer's disease
* Presence of an active infection within 2 weeks prior to the surgical procedure
* Preoperative hospitalization \> 2 days
* Concurrent surgery on the aorta or heart valves
* Urgent or emergency nature of the surgical procedure
* Re-sternotomy aimed at surgical re-exploration of bleeding or implementation of cardiopulmonary resuscitation (CPR) in cases of cardiac arrest
* Patients in whom the sternum has not been closed after the completion of the surgical procedure and who are transferred to the cardiothoracic unit without sternum closure
* Active endocarditis
* Life expectancy \< 6 months
* Lack of a smartphone
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hellenic Mediterranean University

OTHER

Sponsor Role lead

Responsible Party

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Konstantinos Giakoumidakis

Associate Professor, Department of Nursing, School of Health Sciences, Hellenic Mediterranean University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hellenic Mediterranean University

Heraklion, Crete, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Konstantinos Giakoumidakis, RN

Role: CONTACT

6973793489

Paraskevi Kyriazi, RN

Role: CONTACT

6970305170

Facility Contacts

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Konstantinos Giakoumidakis, Associate Professor

Role: primary

00306973793489

Paraskevi Kyriazi, PhD candidate

Role: backup

00306970305170

Konstantinos Giakoumidakis, Associate Professor

Role: backup

Paraskevi Kyriazi, PhD candidate

Role: backup

Other Identifiers

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7414/10.01.2024

Identifier Type: -

Identifier Source: org_study_id

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