Tumescent Anesthesia Antibiotic Delivery (TAAD) and SubQKath for Prevention of Surgical Site Infection, Thrombosis and Sepsis
试验速览
- 阶段
- 2 期
- 入组人数
- 330
- 主要终点
- Sepsis
研究概览
简要总结
This is a multicenter randomized clinical trial (RCT) comparing two modes of antibiotic delivery:
Control: Intravenous Antibiotic Delivery (IVAD) Treatment: IVAD + TAAD The Food & Drug Administration (FDA) has approved our Investigational New Drug (IND) application to conduct this RCT. An IND application was necessary because subcutaneous injection of antibiotics in general, and cefazolin and metronidazole in particular are considered to be "off-label". In addition, the tumescent formulation of cefazolin (1gm) and metronidazole (500mg/100ml) in a dilute solution of lidocaine (1gm), epinephrine (1mg) in 100ml and sodium bicarbonate (10mEq/10ml) added a 1000ml bag of 0.9% sodium chloride (total volume 1210ml) is also considered "off-label." This trial will also prospectively study the HK Surgical SubQKath, an over-the-needle subcutaneous catheter specifically designed to deliver relatively large volumes of a relatively dilute TAAD solution. The TAAD trial will document the safety and efficacy of the HK SubQKath
详细描述
Based on the approval of an investigational new drug (IND) application, the present clinical trial of TAAD of cefazolin and metronidazole has been approved by the Division of Anti-Infective Products (DAIP).
Despite the use of multiple interventions, surgical site infection (SSI) continues to be a significant problem. There is a need for an effective, accessible, inexpensive, simple, safe technique that reduces the risk of SSI. Intravenous antibiotic delivery (IVAD) using an over-the-needle intravenous (IV) catheter is the current standard mode of antibiotic delivery for SSI prevention.
- Subcutaneous delivery of an antibiotics such as cefazolin and metronidazole is considered by the FDA to be off-label.
- Subcutaneous infiltration of dilute a tumescent lidocaine solution (with or without antibiotics) at lidocaine dosages between 7mg/kg and 28mg/kg is off-label.
- Subcutaneous infiltration of dilute antibiotic(s) in a tumescent lidocaine solution using a novel over-the-needle subcutaneous catheter (SubQKath), having holes distributed along most of the length of the cannula length, requires FDA 510(k) approval.
This multicenter randomized clinical trial (RCT) protocol is designed to
- compare two modes of antibiotic delivery,
- validate the safety of tumescent lidocaine at dosages up to 28mg/kg,
- validate the safety of the SubQKath for tumescent anesthetic antibiotic delivery (TAAD).
- This protocol is not a clinical trial comparing the effects of different drugs.
- This RCT compares IVAD alone versus concomitant TAAD and IVAD (TAAD+IVAD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Persons making decision to categorize the outcome as either "Infection Occurred" or "No Infection Occurred" will be masked with respect to whether or not the subject received Standard pre-operative IV antibiotics alone or received both IV antibiotics and tumescent anesthesia & antibiotic delivery (TAAD).
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
- •Subjects greater than 18 years of age scheduled for surgical procedures considered to have a high risk for a surgical site infection (SSI) such as 1) secondary repair of a ventral hernia, 2) open bariatric surgery, 3) open abdominal colorectal surgery, 4) trauma surgery, 5) burn surgery or 6) sternotomy.
- •Patients ought to have one of the following risk factors for surgical site infection: emergency surgery, obesity, diabetes mellitus, cancer surgery, be immune-compromised or otherwise be at an increased risk for SSI, or be in a medically indigent environment where surgical aseptic technique is suboptimal
排除标准
- •Pre-existing skin infection Pregnant Less than 18 years old
研究组 & 干预措施
IVAD
IV antibiotic delivery (IVAD) alone as surgical site infection prevention. The intervention is IV antibiotics alone.
干预措施: Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD (Drug)
TAAD + IVAD
Both subcutaneous tumescent anesthesia & antibiotic delivery (TAAD) and IVADThe The intervention is subcutanious and IV antibiotics
干预措施: Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD (Drug)
TAAD + IVAD
Both subcutaneous tumescent anesthesia & antibiotic delivery (TAAD) and IVADThe The intervention is subcutanious and IV antibiotics
干预措施: SubQKath (Device)
结局指标
主要结局
Sepsis
时间窗: within 30 of surgical procedure
Diagnosis of Post-operative sepsis
Adverse event associated with SubQKath device
时间窗: within 30 of surgical procedure
any adverse event
Post-operative venous thromboembolism
时间窗: within 30 of surgical procedure
Diagnosis of Post-operative venous thromboembolism
surgical site infection (SSI)
时间窗: within 30 of surgical procedure
Occurrence of a surgical site infection (SSI)
次要结局
- General Anesthesia Requirements (Quantitative Measure)(day of surgery)
- Diagnosis of C. Difficile colitis(30 Days Postop)
- Length of Stay (LOS) in hospital after surgery (hours)(60 days)
- Time in post-operative/post-anesthesia recovery unit.(30 days post-op)
- Post-Op Narcotic Requirements (total mg and mg/kg)(30 days post op)