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

NCT06651268 | Unknown Phase 1 DMC

• 1 other identifier: LNH-2024
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Wound Complication; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of sternal wound infections (SWIs) following cardiac 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

Study Arms (2)

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

EXPERIMENTAL

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

OTHER

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

Interventions

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

: Group A (control, n=12) received standard closure techniques without vancomycin powder; while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 21 and 80 years were included in the study.
• Both male and female participants were eligible.

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Cardiac Surgery

Karachi, Sindh, 74201, Pakistan

Location

Central Study Contacts

Qaiser Aziz qaiserazizdr@hotmail.com, FCPS

CONTACT

+923362405480; qaiserazizdr@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Surgery

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: November 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 1, 2025
• Last Updated: October 28, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)