Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial
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
1 other identifier
interventional
220
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2024
CompletedFirst Submitted
Initial submission to the registry
September 4, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedSeptember 19, 2024
September 1, 2024
1 year
September 4, 2024
September 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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).
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).
six months
Study Arms (3)
Control group: Group A
NO INTERVENTIONNo 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
EXPERIMENTALThe 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 C: nurse-led education and implementation of teleinterventions
EXPERIMENTALThe 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
Interventions
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 An educational video, made for the purposes of the study only, will be shown to them. This is the difference between the two groups
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hellenic Mediterranean University
Heraklion, Crete, 71410, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Nursing, School of Health Sciences, Hellenic Mediterranean University
Study Record Dates
First Submitted
September 4, 2024
First Posted
September 19, 2024
Study Start
March 1, 2024
Primary Completion
March 1, 2025
Study Completion
September 1, 2025
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share