NCT07130422

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
Last Updated

August 19, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 12, 2025

Last Update Submit

August 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    30 days post-CABG

Study Arms (1)

CABG surgery

Procedure: CABG surgery

Interventions

CABG surgeryPROCEDURE

CABG surgery

CABG surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Adults aged 18 years or older
  • Undergoing isolated coronary artery bypass graft (CABG) surgery
  • Elective surgical cases

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital, Kathmandu, Nepal

Kathmandu, Nepal

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2025

First Posted

August 19, 2025

Study Start

July 1, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

August 19, 2025

Record last verified: 2025-08

Locations