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

Not Applicable

Recruiting

• Conditions: Surgical Site Infection; Coronary Artery Bypass Grafting (CABG)

• Registration Number: NCT06586749
• Lead Sponsor: Hellenic Mediterranean University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-06
• Last Update Posted: 2024-09-06
• Primary Completion: 2025-03-01
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
nurse-led education and nursing teleinterventions on reducing the incidence of surgical site infections (SSIs) in patients who underwent planned coronary artery bypass grafting (CABG).	six months	To investigate the effect of nurse-led education and the implementation of systematic nursing teleinterventions on reducing the incidence of surgical site infections (SSIs) in patients who underwent planned coronary artery bypass grafting (CABG).

Trial Locations

Locations (1)

Hellenic Mediterranean University; 🇬🇷 Heraklion, Crete, Greece