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

Hellenic Mediterranean University

Status: Enrolling

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

Treatments: Other: Group C: nurse-led education and implementation of teleinterventions; Other: Group B: nurse-led education

Study type: Interventional

Funder types: Other

Identifiers

NCT06586749

7414/10.01.2024

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

Control group: Group A

No Intervention group

Description:

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 B: nurse-led education

Experimental group

Description:

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.

Treatment:

Other: Group B: nurse-led education

Group C: nurse-led education and implementation of teleinterventions

Experimental group

Description:

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

Treatment:

Other: Group C: nurse-led education and implementation of teleinterventions