Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery

October 24, 2024 updated by: Qaiser Aziz, Liaquat National Hospital & Medical College

Local Application of Vancomycin (powder) Before Surgical Closure Helps to Reduce Sternal Wound Infection After Cardiac Surgery Procedures.

Title: The Role of Vancomycin Powder in Reducing Sternal Wound Infections Following Cardiac Surgery: A Randomized Controlled Trial

Introduction:

Sternal wound infections (SWIs) are significant complications in cardiac surgery, leading to serious issues like mediastinitis, prolonged hospital stays, and higher healthcare costs. This study explores the potential of topical vancomycin powder to reduce SWIs when added to the standard use of systemic antibiotics.

Objectives:

To assess the effectiveness of vancomycin powder in preventing SWIs post-cardiac surgery.

To determine its impact on postoperative hospital stays.

Study Design and Methodology:

A randomized controlled trial will be conducted at Liaquat National Hospital, Karachi, with 24 patients (12 in each group).

Group A will receive standard wound closure, while Group B will receive vancomycin powder applied to the sternal wound.

Postoperative wound assessments will be conducted at 48 hours, 7 days, and 1 month.

Ethical Considerations:

Ethical approval will be obtained, and informed consent will be sought from all participants

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The sternotomy approach is widely used in cardiac surgeries, making sternal wound infections a significant concern. These infections can lead to serious complications, including sepsis, reoperation, and increased healthcare costs. Systemic antibiotic prophylaxis is a common practice, but local antibiotic application at the surgical site could further reduce the risk of infection. Vancomycin, due to its effectiveness against gram-positive bacteria, is an ideal candidate for local application. Previous studies in orthopedic surgeries have demonstrated reduced infection rates with vancomycin powder, but its efficacy in cardiac surgery has not been thoroughly explored. This study aims to investigate whether local application of vancomycin powder reduces the incidence of sternal wound infections after cardiac surgery compared to standard care. Additionally, it will evaluate secondary outcomes such as hospital stay duration, postoperative morbidity, and wound-related complications, including dehiscence and the need for reoperation.

The study will be a randomized controlled trial conducted at Liaquat National Hospital, Karachi, Pakistan. A total of 24 patients undergoing cardiac surgery will be randomly allocated to either a control group (standard closure technique) or an intervention group (1 gram of vancomycin powder applied locally before sternal closure). Both groups will receive systemic antibiotic prophylaxis as part of routine care.

This study aims to provide evidence on the efficacy of local vancomycin powder application in reducing sternal wound infections after cardiac surgery. If successful, it could offer a simple, cost-effective intervention to improve postoperative outcomes in cardiac surgery patients. Further research may be needed to validate the findings and support its widespread implementation.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • .Patients aged between 21 and 80 years were included in the study.
  • Both male and female participants were eligible.
  • Patients undergoing various adult cardiac surgical procedures, including coronary artery bypass grafting (CABG), atrial septal defect (ASD) repair, ventricular septal defect (VSD) repair, and valve replacement, were considered for inclusion.

Exclusion Criteria:

  • Patients who did not provide informed consent were excluded from the study.
  • Individuals with a known sensitivity to vancomycin were not eligible.
  • Pediatric patients were excluded.
  • Patients undergoing redo surgeries were also excluded from participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
Other: : Group A (control, n=12) received standard closure techniques without vancomycin powder
Group A (control, n=12) received standard closure techniques without vancomycin powder
Drug: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T
while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of sternal wound infections (SWIs) following cardiac surgery
Time Frame: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery
Incidence of sternal wound infections (SWIs) following cardiac surgery in patients who receive vancomycin powder application compared to those who do not. The infections would be diagnosed based on clinical signs such as redness, pain, swelling, and purulent discharge at the wound site.
he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat National Hospital & Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

October 18, 2024

First Posted (Actual)

October 21, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LNH-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to privacy issue

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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