Randomized, Controlled, Single-blinded Trial to Evaluate the Efficacy and Safety of Intra-wound Administration of Vancomycin Powder as Add-on Prophylactic Intraoperative Antibiotic in Patients at High Risk for Surgical Site Infections After Receiving Open Posterior Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Incidence of deep incisional SSI
研究概览
简要总结
Surgical site infections (SSI) are not uncommon, especially in specific high-risk groups including spinal deformity and tumor (i.e. metastatic spine surgery) surgery. Well-recognized measures have been adopted to reduce surgical site infection, and the use of topical vancomycin powder has gained popularity in recent years. Given the lack of high-quality evidence for the use of topical vancomycin to reduce surgical site infections in open posterior spine surgery, which is currently the most common approach to spine surgery, it is crucial to study the use of vancomycin powder in reducing surgical site infections. This study is a prospective, single-blinded open label randomized controlled trial, with one arm of patients having local administration of 1g vancomycin powder which will be placed in the deep wound and subcutaneous layer prior to closure of surgical site by the orthopaedic surgeon, whereas the control arm will be without such application of vancomycin. Both arms of patients will still be undergoing the same operation procedures, as well as postoperative local wound drainage and wound care. This study will provide insights on the reduction rate in superficial and/or deep surgical site infection, and also assess the cost-effectiveness of using topical vancomycin in reducing surgical site infection between different disease groups, as well as any postoperative serum vancomycin toxicity and renal impairment. These proposed findings will provide valuable information for clinicians and institutions on future measures for surgical site infection of open posterior spine surgery.
详细描述
Objectives:
Primary Objectives:
To evaluate the efficacy of intra-wound administration of vancomycin powder as add-on prophylactic intraoperative antibiotic in patients at high risk for surgical site infections after receiving open posterior spinal surgery
Secondary Objectives:
- To evaluate the safety of intra-wound administration of vancomycin powder as an add-on prophylactic intraoperative antibiotic
- To evaluate the cost-effectiveness of intra-wound administration of vancomycin powder as an add-on prophylactic intraoperative antibiotic compared to standard prophylactic intraoperative care
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
This will be a single blinded trial as patients will not know their treatment allocation until the termination of study. Operating surgeons cannot be blinded to allocation. However, all clinical and radiological outcomes will be evaluated by an independent researcher who is blinded to the allocation. This researcher will be blinded to the study treatment throughout the study period.
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
- •Female or male adult with age ≥18 years
- •Undergoing open posterior spinal surgery with instrumentation indicated for spinal deformity, trauma and tumor
- •Able to understand the nature, scope and possible consequences of participation in the study
- •Appropriate voluntary written informed consent have been provided by patients
排除标准
- •Has been treated with antibiotics due to primary spinal infection (i.e. spondylodiscitis) within 1 year prior to surgery
- •Ongoing treatment with antibiotics for other infections
- •Undergoing minimally invasive surgery or anterior-only surgical approaches or deformity correction surgery for adolescent idiopathic scoliosis (inherent low-risk for surgical site infections18)
- •Undergoing decompression-only surgery for cervical spine, spinal deformity, trauma and tumors
- •Has known history of allergy to vancomycin, penicillin and other glycopeptides (teicoplanin)
- •Has history of vancomycin resistance
研究组 & 干预措施
Intervention - Vancomycin
Intervention: 1g vancomycin powder locally applied to the deep wound and subcutaneous layer prior to closure.
干预措施: Vancomycin powder (Drug)
Control - No vancomycin application
No intervention, control group All other wound closure procedure and wound care and monitoring are the same
结局指标
主要结局
Incidence of deep incisional SSI
时间窗: one year
Deep Incisional SSI (DSSI) 1. For deep incisional SSI, the definition is an infection occurring within 90 days after the operation (where day 1 = the procedure day); AND 2. Involves deep soft tissues of the incision (e.g. fascial and muscle layers); AND 3. Patient has at least one of the following: 1. purulent drainage from the deep incision; 2. a deep incision spontaneously dehisces, or is deliberately opened or aspirated by the surgeon, attending doctor or other designee; AND Organism(s) identified from the deep soft tissues of the incision by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment; AND Patient has at least one of the following signs and symptoms: fever (\>38 °C); localized pain or tenderness; 3. An abscess or other evidence of infection involving the deep incision that is detected on gross anatomical or histopathologic exam, or imaging test.
Number of participants with adverse event (AE) to vancomycin
时间窗: one year
An AE is any untoward medical occurrence to a patient which does not necessarily has a causal relationship with the study intervention, and it can also occur outside of the time period. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), new or exacerbated symptoms/diseases temporally associated with the study intervention, whether or not the event is considered causally related to the use of intervention. Medical conditions/diseases present before the study intervention are only considered as AEs if they worsen after intervention. Signs and symptoms that are clearly due to natural process of underlying disease/disease progression should not be reported. SSSI/DSSI is not regarded as an AE in the study. Secondary infection of a SSSI/DSSI or other infection shall be regarded as an AE. The term AE is used to include both serious and non-serious AE.
Incidence of superficial incisional SSI
时间窗: one year
CDC Surgical Site Infection Criteria (Centers for Disease Control, Procedure-associated Module SSI, January 2019) The definition of SSSI is: 1. an infection occurs within 30 days after operation (where day 1= operation day); AND 2. Involves only skin/subcutaneous tissue of the incision; AND 3\) Patient has at least one of the following: a)purulent drainage from the superficial incision; b)organism(s) identified from an aseptically-obtained specimen from the superficial incision or subcutaneous tissue by a culture/non-culture based microbiologic testing method; c)superficial incision being deliberately opened by a surgeon, attending doctor/other designee and culture/non-culture based testing of the superficial incision or subcutaneous tissue is not performed AND Patient has at least one of the following: localized pain/tenderness, localized swelling, erythema, or heat; d) SSSI diagnosed by a surgeon, attending doctor/other designee.
次要结局
- Cost-effectiveness of vancomycin use(one year)
- Incremental cost-effectiveness ratio(one year)
- Serum vancomycin level(Three days postoperatively)
- Renal function test(Three days postoperatively)
研究者
Dr. Jason Pui Yin Cheung
Associate Professor
The University of Hong Kong