Pragmatic Multicentre FActorial Randomised Controlled triaL Testing Measures to reduCe Surgical Site Infection in lOw and Middle Income couNtries
试验速览
- 阶段
- 3 期
- 入组人数
- 5,480
- 试验地点
- 1
- 主要终点
- Surgical site infection (SSI)
研究概览
简要总结
FALCON is a Pragmatic multi-centre trial testing measures to reduce superficial or deep skin infection following abdominal surgery in low and middle income countries. The trial will recruit patients undergoing abdominal surgery. Recruited participants will be randomly assigned to four arms to receive different combinations of skin preparation and sutures for would closure:
A. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and non-coated suture for wound closure; B. In this arm surgeon will use 2% alcoholic chlorhexidine for skin cleansing and triclosan coated suture for wound closure; C. In this arm surgeon will use for operation 10% aqueous povidone-iodine for skin cleansing and non-coated suture for wound closure; D. In this arm surgeon will use 10% aqueous povidone-iodine for skin cleansing and triclosan-coated suture.
详细描述
FALCON is a pragmatic, blinded (patient and outcome assessor), 2x2 factorial, stratified, multi-centre randomised controlled trial, with an internal pilot, to evaluate measures to reduce Surgical Site Infection (SSI) rates in patients undergoing surgery with an abdominal incision.
Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work (3). SSIs increase healthcare costs in all health settings. Whilst there is no direct data on the costs of SSI in LMICs, within the UK National Health Service, SSIs cost approximately £3500 per patient and £700 million per year in total. The impact of increased healthcare costs on patients, communities, and providers can be major in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a hospital acquired infection.
Strata in FALCON trial are defined according to the anticipated category of wound contamination: (1) clean-contaminated and (2) contaminated/dirty. Eligible patients will be randomised at the level of the individual in a 1:1:1:1 ratio between:
A. 2% alcoholic chlorhexidine and non-coated suture B. 2% alcoholic chlorhexidine and triclosan-coated suture C. 10% aqueous povidone-iodine and non-coated suture D. 10% aqueous povidone-iodine and triclosan-coated suture.
Participant will be recruited from hospitals in Low and Middle Income Countries (LMICs). Participants who is undergoing abdominal surgery with an anticipated clean-contaminated, contaminated or dirty surgical wound will be selected to enter the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and outcome assessors will be blinded. The operating surgeon will not perform outcome assessment.
入排标准
- 年龄范围
- — 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with at least one abdominal incision that is ≥5cm (open or laparoscopic extraction site), with an anticipated clean-contaminated, contaminated or dirty surgical wound.
- •Patients undergoing emergency (surgery on an unplanned admission) or elective (surgery on a planned admission) operations.
- •Any operative indication, including trauma surgery.
- •Patient able and willing to provide written informed consent (signature or a fingerprint).
- •Paediatric and adult patients. This criteria is made country-specific. Each country decides the lower age limit for the trial. This is dependent on country-specific regulatory approvals. Age eligibility will vary by country.
排除标准
- •Patients with a documented or suspected allergy to iodine, shellfish, or chlorhexidine skin preparation solution.
- •Patient unable to complete post-operative follow-up (i.e. will not be contactable after discharge).
研究组 & 干预措施
2%chlorhexidine + non-coated suture
2%alcoholic chlorhexidine + non-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with non-coated suture for abdominal fascial closure.
干预措施: 2% chlorhexidine + non-coated suture (Drug)
2%chlorhexidine + coated suture
2%alcoholic chlorhexidine + triclosan-coated suture. Intervention: skin preparation with 2%alcoholic chlorhexidine in combination with triclosan-coated suture for abdominal fascia closure.
干预措施: 2% chlorhexidine + coated suture (Drug)
10% povidone-iodine + non-coated suture
10% povidone-iodine and non-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with non-coated suture for abdominal fascial closure.
干预措施: 10%povidone-iodine + non-coated suture (Drug)
10%povidone-iodine + coated suture
10%povidone-iodine/triclosan-coated suture. Intervention: skin preparation with 10% povidone-iodine in combination with triclosan-coated suture for abdominal fascial closure.
干预措施: 10%povidone-iodine + coated suture (Drug)
结局指标
主要结局
Surgical site infection (SSI)
时间窗: At 30-days post-surgery
Deep incisional or superficial incisional SSI which must occur within 30 days of the index operation. The infection must involve the skin, subcutaneous, muscular or fascial layers of the incision. Patient must at least have one of the following: (1) purulent discharge from wound; (2) organisms detected from wound swab; (3) Wound opened spontaneously or by a clinician AND, at the surgical wound, the patient has at least one of: pain or tenderness; localised swelling; redness; heat; systemic fever (\>38°C); (4) Diagnosis of SSI by a clinician or on imaging.
次要结局
- Physiological parameter - SSI at discharge from hospital(Within 30-days post surgery from index operation)
- Length of hospital stay for index admission(Within 30-days post surgery from index operation)
- Participant's Readmission(Within 30-days post surgery from index operation)
- Mortality - patient mortality status(Within 30-days post surgery from index operation)
- Resistance of organisms(Within 30-days post surgery from index operation)
- Questionnaire - Health resource usage(Within 30-days post surgery. Health resource usage will only be collected for adult patients (aged 18 and above) at pre-selected centres. This will include costs of post-operative visits to various healthcare professionals.)
- Physiological parameter - Unplanned wound opening(Within 30-days post surgery from index operation)
- Re-operation for SSI(Within 30-days post surgery from index operation)
- Questionnaire - return to normal activities(Within 30-days post surgery from index operation)