SUpPress SSI - Single Use Negative Pressure Wound Therapy (NPWT) to Reduce Surgical Site Infections
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,680
- 试验地点
- 10
- 主要终点
- Surgical Site Infection Rate per 100 surgeries
研究概览
简要总结
Our goal is to provide data that will give surgeons and hospitals clear recommendations on the use of NPWT for Cesarean section, abdominal hysterectomy and colon surgeries in patients with diabetes and/or obesity. We also want to understand the patient experience with the dressing so that we can provide information that will enable clinicians to remove barriers to NPWT use. Additionally, we are seeking to use automated electronic medical record decision support to identify patients that will benefit most from the NPWT.
详细描述
Specific Aim 1: Evaluate the effect of single-use NPWT on SSI rates after C-section, abdominal hysterectomy, and colon procedures in at risk patients.
To address this aim, we will conduct multicenter, stepped-wedge, quasi-experimental trial evaluating use of the PrevenaTM with 125 mm Hg negative pressure for 7 days among obese (BMI >30) and/or diabetic patients undergoing the procedures of interest. This is essentially a phase IV clinical trial as this dressing has FDA approval for the indicated use.
Specific Aim 2: Investigate the patients' experience of using the NPWT. To achieve this aim, we will survey a sub-set of patients to assess their knowledge of post-operative care, to identify complications associated with NPWT use, and to learn how patients evaluated the device's ease of use, ease of removal, and comfort.
Specific Aim 3: Assess whether real-time decision support through machine-learning modeling can help surgeons identify patients at high risk of SSI who could benefit from NWPT or other post-surgical preventive measures. To address this aim, we will evaluate whether boosted tree modeling techniques can be used "at the bedside" via electronic medical record data feeds to tailor post-operative care and preventive care for specific patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
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
- •Category A and B
- •A. Patients undergoing any of the below procedures:
- •abdominal hysterectomy
- •colon procedures Surgical procedures selected will be based on NHSN designated ICD-10 PCS codes(14), with the exclusion of laparoscopic procedures.
- •B. and either of the following medical conditions:
- •obesity, BMI >30 kg/m2
- •diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the problem list or the medical history or Patient is taking a medication as treatment for diabetes, consistent with NHSN criteria(10).
排除标准
- •Age less than 18 years
- •Infection present at the time of the surgery
- •Laparoscopic procedures with incisions <6cm.
- •Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure
结局指标
主要结局
Surgical Site Infection Rate per 100 surgeries
时间窗: within 30 days after surgery
Superficial , Deep and organ space infections after surgery
次要结局
- REadmission incidence and rate per 100 surgeries(within 30 days)
- Post Operative Length of Stay (days)(within 30days after surgery)
- Dehiscence incidence and rate per 100 surgeries(within 30 days after surgery)
- Seroma incidence and rate per 100 surgeries(with in 30 days after surgery)
- Hematoma incidence and rate per 100 surgeries(within 30 days after surgery)
研究者
Susan Casey Bleasdale
Associate Professor of Clinical Medicine
University of Illinois at Chicago