A Randomised Control Trial to Determine Whether a 5 Day Course of Antibiotics is More Clinically and Cost Effective Than a 24 Hour Prophylactic Course for the Prevention of Surgical Site Infection Following Lower Limb Amputation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Surgical Site Infection
研究概览
简要总结
- Lower limb amputations are performed usually as a last resort in patients with acute and chronic limb ischaemia (CLI) caused by vascular disease, poorly controlled diabetes or, infection.
- In the period 2003-2008 there were approximately 5,000 amputations per year in the UK.
- The Centre for Disease Control defines a Surgical Site Infection (SSI) as an infection within 30 days of an operation or up to one year if an implant is left in place and the infection is related to an operative procedure.
- Figures from the Surgical Site Infection Surveillance reported that the highest rate of surgical site infection was reported in association with lower limb amputation at 13.1%.
- There is a clear under-representation and the infection rate within our institution is approximately 25% which reflects the infection rate reported in a recent trial by Sadat et al (22.5%)
- Prevention of surgical site infections is of paramount importance to patients, healthcare providers and policy-makers, as they impact on morbidity and mortality and have significant time and cost implications.
- Currently there is NO CONSENSUS as to what the best practice is towards antibiotic administration in such patients. From a questionnaire-based audit we performed including vascular departments across the entire country, practice varies in both course duration (single dose → 5 days antibiotic course) as well as choice of antibiotics.
- The guideline at our institution suggests the 5-day course of antibiotic prophylaxis. The course duration varies depending on the clinical picture as well as microbiology results and recommendations.
- There are no randomised control trials that have investigated this aspect of patient care. We have set up one such trial and through it, we are looking to establish a standard practice which will hopefully be as beneficial as possible to the patient but also cost-effective for NHS.
详细描述
As above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 yrs undergoing lower limb amputations who are able to consent to the trial.
- •Able to understand the Patient Information Sheet and capable and willing to give informed consent and follow the protocol requirements (including attending all follow-up visits)
排除标准
- •Allergies to chlorhexidine/ alcohol/ iodophors
- •Inability to give informed consent
- •Patients who are admitted to hospital with severe sepsis secondary to gas gangrene requiring multiple operations and admission to Intensive Care Unit.
- •Aged under 18 years at the time of recruitment
- •Use of investigational drug/device therapy within preceding 4 weeks that may interfere with this study.
- •Toe amputations
研究组 & 干预措施
24 hour antibiotic course
24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)
干预措施: Co-amoxiclav (Drug)
24 hour antibiotic course
24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)
干预措施: Iodine (Drug)
24 hour antibiotic course
24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)
干预措施: Metronidazole (Drug)
24 hour antibiotic course
24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)
干预措施: Chlorhexidine (Drug)
24 hour antibiotic course
24 hours of the stated antibiotics administered intravenously (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function)
干预措施: Teicoplanin (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Co-amoxiclav (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Iodine (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Metronidazole (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Chlorhexidine (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Teicoplanin (Drug)
5 day antibiotic Course
24 hours of IV antibiotics followed by 4 days of oral antibiotics (Augmentin and metronidazole. Teicoplanin and or gentamicin will be used if penicillin allergic and state of renal function. Clindamycin will be used as a an oral replacement for penicillin allergic patients)
干预措施: Clindamycin (Drug)
Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
干预措施: Co-amoxiclav (Drug)
Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
干预措施: Iodine (Drug)
Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
干预措施: Metronidazole (Drug)
Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
干预措施: Teicoplanin (Drug)
Iodine
Skin Preparation used pre-operatively: Alcoholic Povidone
干预措施: Clindamycin (Drug)
Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
干预措施: Co-amoxiclav (Drug)
Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
干预措施: Metronidazole (Drug)
Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
干预措施: Chlorhexidine (Drug)
Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
干预措施: Teicoplanin (Drug)
Chlorhexidine
Skin preparation to be used preoperatively: Alcoholic chlorhexidine
干预措施: Clindamycin (Drug)
结局指标
主要结局
Surgical Site Infection
时间窗: 30 days
Primary objective: to establish the effect of 5 days of antibiotics versus a 24-hour prophylactic course on the incidence of surgical site infection (SSI) - total ASEPSIS score \>21
次要结局
- Pain Control(1 year)
- Mobility(1 year)
- Satisfactory healing rates(3 months)
- Resource use(up to 3 months)
- Quality of life Questionnaire(1 year)
- Rate of C. Diff., MSSA (Methicillin Sensitive Staphylococcus Aureus), MRSA (Methicillin Resistant Staphylococcus Aureus) infection(30 days)
- Rate of re-intervention(30 days)
- Mortality(1 year)
- Impact of different skin preparations on infection rates(30 days)