Surgical Site InfectionNCT06586749
Effect of Nurse-Led Education and Tele-Interventions on Reducing Surgical Site Infections in Patients After Coronary Artery Bypass Surgery: a Clinical Trial
A study testing Group B: nurse-led education and Group C: nurse-led education and implementation of teleinterventions in people with Surgical Site Infection and Coronary Artery Bypass Grafting (CABG), run by Hellenic Mediterranean University at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Coronary Artery Bypass Grafting (CABG)
- What is being tested?
- Group B: nurse-led education and Group C: nurse-led education and implementation of teleinterventions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteGreece
- Study dates
- 1 Mar 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Hellenic Mediterranean University
Heraklion, Crete, 71410
Konstantinos Giakoumidakis, Associate Professor, 00306973793489, kongiakoumidakis@hmu.gr
Paraskevi Kyriazi, PhD candidate, 00306970305170, ddk224@edu.hmu.gr
About this study
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
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?
Read more
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
- Being tested
- Group B: nurse-led education, Group C: nurse-led education and implementation of teleinterventions
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B: nurse-led educationOther
Group B: nurse-led education No educational video, will be shown to this group of patients
Group C: nurse-led education and implementation of teleinterventionsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Control group: Group A | No intervention | 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 | 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. Receives: Other: Group B: nurse-led education |
| Group C: nurse-led education and implementation of teleinterventions | Experimental | 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 Receives: Other: Group C: nurse-led education and implementation of teleinterventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hellenic Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantinos Giakoumidakis, Hellenic Mediterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586749
- Sponsor's protocol ID
- 7414/10.01.2024
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06586749
- Acronym / sponsor ID
- 7414/10.01.2024
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hellenic Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group: Group A | No intervention | –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 | Other: Group B: nurse-led educationThe 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 | Experimental | Other: Group C: nurse-led education and implementation of teleinterventionsThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group B: nurse-led educationGroup B: nurse-led education No educational video, will be shown to this group of patients | Other | Group B: nurse-led education |
| Group C: nurse-led education and implementation of teleinterventionsGroup 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 | Other | Group C: nurse-led education and implementation of teleinterventions |
Primary outcome
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).
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group B: nurse-led education and Group C: nurse-led education and implementation of teleinterventions in people with Surgical Site Infection and Coronary Artery Bypass Grafting (CABG), run by Hellenic Mediterranean University at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Konstantinos Giakoumidakis, RN (6973793489, kongiakoumidakis@hmu.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.