A Phase 1/2 interventional study of while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T in Wound Complication and Cardiac Surgery, sponsored by Liaquat National Hospital & Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Liaquat National Hospital & Medical College · Phase 1/2, Interventional, and Prevention
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
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.
382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.
This study's planned enrollment of 24 is below the median of 150 across 296 interventional studies indexed under Wound Infection.
Browse Wound Infection studies →Liaquat National Hospital & Medical College is the lead sponsor of 33 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
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
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
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.
Time frame: he patients will be evaluated at three key time points: 48 hours post-surgery 7 days post-surgery 1 month post-surgery
Plan to share: No — Due to privacy issue
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Liaquat National Hospital & Medical College