CABGNCT07130422
Incidence and Risk Factors of Surgical Site Infections After Coronary Artery Bypass Grafting Surgery
An observational study of CABG, run by Maharajgunj Medical Campus at 1 site in Nepal.
Trial summary
The burden of coronary artery disease (CAD) is increasing in the Nepalese population. Coronary artery bypass grafting (CABG) remains one of the most frequently performed surgical interventions for the management of advanced CAD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CABG
- What is being tested?
- CABG surgery
- Type of treatment
- Surgery or procedure
- How many people
- 89 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jul 2023to 1 Jun 2024
- Phase
- Observational
- 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
Study population: The study was conducted at Manmohan Cardio Thoracic Vascular and Transplant Center (MCVTC), a national tertiary referral center in Nepal performing over 20% of the country's cardiac surgeries. Using convenience sampling, adults (≥18 years) undergoing elective, isolated CABG were included. Patients having combined cardiac procedures, penicillin/cephalosporin allergy, refusal of consent, or loss to follow-up within 30 days were excluded.
Who may be able to join
- Adults aged 18 years or older
- Undergoing isolated coronary artery bypass graft (CABG) surgery
- Elective surgical cases
Who cannot join
- CABG performed in combination with other cardiac procedures (e.g., valve surgery, aortic aneurysm repair, congenital heart surgery)
- Known allergy to penicillin or cephalosporins
- Refusal to provide informed consent
- Loss to follow-up within 30 days after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Risk Factors of Surgical Site Infections After Coronary Artery Bypass Grafting Surgery: A Prospective Observational Study in a Tertiary Care Center in Nepal
The burden of coronary artery disease (CAD) is increasing in the Nepalese population. Coronary artery bypass grafting (CABG) remains one of the most frequently performed surgical interventions for the management of advanced CAD. Despite this, there is a paucity of data regarding the incidence and determinants of surgical site infections (SSIs) following CABG in the Nepalese context. This study aimed to determine the incidence of SSIs after CABG surgery in the Nepalese population.
- Conditions
- CABG
- Being tested
- CABG surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CABG surgeryProcedure or surgery
CABG surgery
| Study group | Role | What they receive |
|---|---|---|
| CABG surgery | Not described Receives: Procedure: CABG surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI) Following Coronary Artery Bypass Grafting (CABG)
The study aims to assess the proportion of patients developing surgical site infections within the first 30 days after undergoing coronary artery bypass graft surgery. SSIs will be identified based on standardized diagnostic criteria, and cases will be classified according to infection depth and site. Data collection will include clinical examination findings, laboratory results, and relevant imaging, ensuring comprehensive identification and categorization of infections.
Measured: 30 days post-CABG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Jul 2023
- Primary completion1 Jun 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CABGStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maharajgunj Medical Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prajjwol Luitel, Maharajgunj Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130422
- Sponsor's protocol ID
- 588(6-11)E2.079/080
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of Surgical Site Infections After Coronary Artery Bypass Grafting Surgery: A Prospective Observational Study in a Tertiary Care Center in Nepal
- ClinicalTrials.gov ID
- NCT07130422
- Acronym / sponsor ID
- 588(6-11)E2.079/080
- Conditions
- CABG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Maharajgunj Medical CampusUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 19 Aug 2025 (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 burden of coronary artery disease (CAD) is increasing in the Nepalese population. Coronary artery bypass grafting (CABG) remains one of the most frequently performed surgical interventions for the management of advanced CAD. Despite this, there is a paucity of data regarding the incidence and determinants of surgical site infections (SSIs) following CABG in the Nepalese context. This study aimed to determine the incidence of SSIs after CABG surgery in the Nepalese population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG surgery | – | Procedure: CABG surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study was conducted at Manmohan Cardio Thoracic Vascular and Transplant Center (MCVTC), a national tertiary referral center in Nepal performing over 20% of the country's cardiac surgeries. Using convenience sampling, adults (≥18 years) undergoing elective, isolated CABG were included. Patients having combined cardiac procedures, penicillin/cephalosporin allergy, refusal of consent, or loss to follow-up within 30 days were excluded.
Key inclusion criteria (3 listed)
- Adults aged 18 years or older
- Undergoing isolated coronary artery bypass graft (CABG) surgery
- Elective surgical cases
Key exclusion criteria (4 listed)
- CABG performed in combination with other cardiac procedures (e.g., valve surgery, aortic aneurysm repair, congenital heart surgery)
- Known allergy to penicillin or cephalosporins
- Refusal to provide informed consent
- Loss to follow-up within 30 days after surgery
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 |
|---|---|---|
| CABG surgeryCABG surgery | Procedure or surgery | CABG surgery |
Primary outcome
Incidence of Surgical Site Infection (SSI) Following Coronary Artery Bypass Grafting (CABG)
Time frame: 30 days post-CABG
The study aims to assess the proportion of patients developing surgical site infections within the first 30 days after undergoing coronary artery bypass graft surgery. SSIs will be identified based on standardized diagnostic criteria, and cases will be classified according to infection depth and site. Data collection will include clinical examination findings, laboratory results, and relevant imaging, ensuring comprehensive identification and categorization of infections.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Coronary Artery Bypass Graft (CABG)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CABG, run by Maharajgunj Medical Campus at 1 site in Nepal.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 19 Aug 2025. 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 Nepal. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (SSI) Following Coronary Artery Bypass Grafting (CABG) (time frame: 30 days post-CABG). 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 Aug 2025.