Clinical trial NCT06586749: Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial
Official title: The Effect of Patient Education and Implementation of Teleinterventions by Nurses, on the Incidence of Surgical Wound Infections, in Patients After Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Surgical Site Infection
Coronary Artery Bypass Grafting (CABG)
Lead sponsor: Hellenic Mediterranean University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Heraklion
country: Greece
facility: Hellenic Mediterranean University
state: Crete
Study officials:
References: