跳至主要内容
临床试验/CTRI/2024/04/065612
CTRI/2024/04/065612尚未招募Phase 3 4

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.

JSS Academy of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年4月22日最近更新:

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

发起方
JSS Academy of Higher Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Boopathy M

JSS Medical College and Hospital, Mysore

研究点 (1)

Loading locations...

相似试验