Randomized Controlled Trial of Intrawound application of Vancomycin powder in Total Hip and Knee Arthroplasty as compared with standard postoperative antibiotics in preventing postoperative infections.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of local application of Vancomycin powder in preventing Surgical Site Infections in patients undergoing Total Hip Replacement and Total Knee Replacement Surgeries
研究概览
简要总结
Following approval from the Institutional Ethical Committee, All Patients admitted in JSS hospital, Department of Orthopaedics, Mysuru above the age of 18 years who will undergo Total Hip Replacement and Total Knee Replacement. After acquiring written, informed consent, Patients will be assessed by a Performa consisting of a series of questions that will contain the necessary information such as patient demographic information such as Age, Sex, Body Mass Index, ASA Classification, diabetes, hemoglobin levels, smoking and alcohol consumption, acute liver disease etc.
Patients who fulfill the inclusion criteria will be taken up for study and after written informed consent, the patient will be randomized into two groups depending upon the local application of Vancomycin powder.
1 gram of Vancomycin is mixed with Normal saline and used for surgical site lavage and 1 gram of Vancomycin powder is applied directly in the wound before closure in the vancomycin group.the Vancomycin group is also given standard post operative antibiotics(Cefuroxime 1.5g). The control group will receive standard post operative antibiotics(Cefuroxime1.5g). Both the groups will be followed for 1 year after the procedure for post operative infections.
Post operatively, patients will be monitored for signs of infection in the early postoperative period, 2 weeks, 6 weeks, 3 months, 6 months and 1 year by clinical examination, radiological, microbiological and blood investigations if necessary.
At the end of study period, both the groups will be statistically compared to come to a conclusionbased on the data obtained from the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All individuals aged 18 years or older who have been admitted in JSS Hospital, Mysuru and are undergoing elective THR, TKR will be used.
排除标准
- •Patients with sepsis, hemodynamic instability or displayed signs of active infection(septic arthritis) 2)Patients with a known allergy to Vancomycin (itchiness, swelling, anaphylactic reaction).
- •Patients undergoing revision THR and Revision TKR.
- •Patients who are immunocompromised.
- •Patients who had previous surgery or history of radiation therapy at the surgical site.
结局指标
主要结局
To evaluate the efficacy of local application of Vancomycin powder in preventing Surgical Site Infections in patients undergoing Total Hip Replacement and Total Knee Replacement Surgeries
时间窗: The time points during which the patients would be assessed are preoperatively, postoperative period (2nd, 5th and tenth day), 2nd week, 6th week, 3rd month, 6th month and 1 year after surgery.
次要结局
- To assess the adverse effects of intrawound application of Vancomycin Powder(Postopertive period, 2nd week, 6th week, 3rd month, 6th month and 1 year after surgery.)
研究者
Dr Boopathy M
JSS Medical College and Hospital, Mysore
