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

NCT ID: NCT06651268

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-10-01

Brief Summary

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

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.

Conditions

Wound Complication; Cardiac Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

Group Type: EXPERIMENTAL

while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

Intervention Type: DRUG

while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

: Group A (control, n=12) received standard closure techniques without vancomycin powder

Group A (control, n=12) received standard closure techniques without vancomycin powder

Group Type: OTHER

while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

Intervention Type: DRUG

while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaquat National Hospital & Medical College

OTHER

Sponsor Role: lead

Responsible Party

Qaiser Aziz

Head of Cardiac Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiac Surgery

Karachi, Sindh, Pakistan

Countries

Pakistan

Central Contacts

Qaiser Aziz qaiserazizdr@hotmail.com, FCPS

Role: CONTACT

qaiserazizdr@hotmail.com

+923362405480

Facility Contacts

Qaisar Aziz Dr, FCPS

Role: primary

qaiserazizdr@hotmail.com

+923362405480

Other Identifiers

LNH-2024

Identifier Type: -

Identifier Source: org_study_id