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临床试验/NCT06651268
NCT06651268尚未招募1 期

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

Liaquat National Hospital & Medical College1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
24
试验地点
1
主要终点
Incidence of sternal wound infections (SWIs) following cardiac surgery

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • .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.

排除标准

  • 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

研究组 & 干预措施

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

Experimental

干预措施: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T (Drug)

: 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

干预措施: while Group B (vancomycin group, n=12) had vancomycin powder applied during closure. T (Drug)

结局指标

主要结局

Incidence of sternal wound infections (SWIs) following cardiac surgery

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Qaiser Aziz

Head of Cardiac Surgery

Liaquat National Hospital & Medical College

研究点 (1)

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