Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery (NCT06651268) | Clinical Trial Compass
UnknownPhase 1/2
Effectiveness of Topical Vancomycin in Reducing Sternal Wound Infections Post-Cardiac Surgery
Pakistan24 participantsStarted 2024-11-01
Plain-language 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
Who can participate
Age range
21 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of sternal wound infections (SWIs) following cardiac surgery
Timeframe: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery
Trial details
NCT IDNCT06651268
SponsorLiaquat National Hospital & Medical College