Evaluation of current trends of antimicrobial prophylaxis in clean Orthopaedic surgeries among Orthopaedicians in India
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- To analyse the antibiotic usage for different Orthopaedic procedures by different surgeons across the country
研究概览
简要总结
Surgical site infections (SSI) are associated with significant morbidity and mortality. Perioperative antibiotic prophylaxis, also frequently known as surgical antibiotic prophylaxis (SAP), is prescribed to reduce the infection risk. The choice of antimicrobial agent and its duration of administration, to an extent, remains a matter of personal choice as local community standards, bacterial resistance and local bacterial flora alter the antibiotic prophylaxis that is required.
Most elective Orthopaedic operations, including joint replacement, are categorised as clean procedures, for which the overall incidence of surgical site infection is low. Factors that increase the likelihood of infection include co-morbid systemic diseases (e.g. diabetes mellitus, rheumatoid arthritis, malignancy); postoperative wound infection; longer duration of surgery (especially over three hours); and previous arthroplasty involving the same joint.
Infections may present within the first month post-operatively or after several months or years. Early infections usually present acutely with overt deep wound infection. Late infections may manifest as increasing pain (particularly at rest), loosening of the prosthesis or sinus formation and discharge. Although the incidence of infection is highest in the first six months, up to half of all prosthetic joint infections present more than two years after the operation.
In most instances, the bacteria responsible for clinical infection of Orthopaedic implants enter the wound at the time of surgery. Such organisms can originate from the patients skin, that of the operating staff, or from circulating dust particles and skin squames in the theatre air. Much less commonly, infection of Orthopaedic implants is the result of blood-borne spread from a distant focus of infection or, even more rarely, follows a bacteraemia-prone procedure (such as bladder catheterisation). The presence of any foreign material greatly reduces the number of bacteria needed to infect the operation site. After joint replacement, the organisms responsible are often bacteria with low virulence in the absence of implanted material, such as coagulase-negative staphylococci. Infection with Staphylococcus aureus is also common, including, increasingly, methicillin-resistant Staphylococcus aureus (MRSA).
Systemic antibiotic prophylaxis in Orthopaedic implant surgeries is the standard practice of care that has been used for the last three decades.
There is enough evidence to say that prophylactic antibiotics should be used in Orthopaedics to reduce SSI. However, three controversial issues persist in the use of prophylactic antibiotics namely; (1) timing of administration (2) which antibiotics to use and (3) duration of prophylactic antibiotics.
The trend in western literature is to use second-generation cephalosporins (cefuroxime) 30 minutes to 1 hour before skin incision and preferable for 24 h to 3 days in intravenous infusion postoperatively. Cefuroxime has high bioavailability in tissue and serum after a single dose and is efficacious for preventing perioperative infection. However, in our scenario, theatre conditions and prevalent pathogens are different. Our patient population has different socioeconomic backgrounds and that cannot be compared with the developed world.
Various surgeons working in different setups (government/private) shall be contacted (in person or telephonically) and requested to fill out an electronic or physical form.
Multiple surgeons shall be contacted in person at major national/international conferences for filling out the forms.
All the data obtained from Google Forms® shall be used to populate the Google Spreadsheet® and analysed using standard statistical tools. Appropriate statistical tests shall be employed to analyse the data.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 25.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •All Orthopaedic surgeons performing multidisciplinary Orthopaedic procedures with a minimum of two Orthopaedic subspecialities & working in: Public Sector Private Sector Maximum three surgeons per institute.
排除标准
- •Surgeons exclusively performing only one type of surgery(subspeciality) Experience after post-graduation of less than 5 years Contaminated wounds Open fractures Fungating tumours.
结局指标
主要结局
To analyse the antibiotic usage for different Orthopaedic procedures by different surgeons across the country
时间窗: At Baseline
次要结局
- Compare national & international trends of antibiotic usage in clean Orthopaedic surgeries & explore reasons for variation.(At baseline)
研究者
Dr Kartik
Pt. B.D. Sharma PGIMS, Rohtak
