Incisional Negative Pressure Dressing on Clean Closed Groin Incisions in High Risk Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Deep wound infection
研究概览
简要总结
Wound complications associated with surgical incisions range from minor to life threatening. Surgical site infections occurring usually occur within 30 days and are one of the most common surgical complications. Perigraft infections in groin wounds can be devastating. Even superficial wounds can progress to deep wounds resulting in graft infection, need for explantation, and sepsis or amputation requirement. Negative pressure wound therapy has had favorable results on closed wounds in trauma populations. Similarly, negative pressure wound therapy has had positive benefits in closed incisions such as sternal wounds following cardiac surgery. As a result, the PrevenaTM Incision Management System(IMS) was developed to allow easier application of negative pressure therapy to closed wounds. Application of the PrevenaTM IMS dressing would portend the aforementioned benefits of Vacuum Assisted Closure (VAC®) therapy with the added benefits of protecting the wound from contamination and bolstering the wound edges for better approximation and consequently better aesthetic outcome. However, no comparison between negative pressure therapy as a dressing and standard wound dressings exists.
The purpose of this study is to assess the efficacy and safety of topical negative pressure therapy application with Prevena™ versus standard of care wound therapy on closed groin incisions in high risk patients undergoing vascular surgery.
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
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 18 years of age or greater
- •Scheduled elective vascular surgery which requires groin incision. Elective surgery is defined as planned surgery a minimum of 24 hours before the procedure.
- •Meets high risk criteria according to the following rating system
- •Scores at least 8 points for the following risk factors:
- •MAJOR 4 points:
- •BMI of <18 kg/m2 or ≥BMI 40 kg/m2 ***
- •Insulin dependent Diabetes Mellitus*
- •Dialysis (hemodialysis or peritoneal dialysis)**
- •INTERMEDIATE 2 points:
- •Previous groin surgery
- •Diabetes Mellitus not requiring insulin*
- •Chronic lung disease GOLD >2
- •On long-term immunosuppressive medication (>3 months at time of enrollment)
- •Chronic kidney disease (defined as a GFR <30ml/min/1.73m2 for 3 months)**
- •Previous lower extremity or abdominal wall radiotherapy radiotherapy
- •BMI between 35 and 40***
- •MINOR 1 point:
- •Previous abdominal surgery
- •Peripheral vascular disease
- •Female gender
- •Age >75 years old
- •Hospitalized at least 7 days before surgery
- •*, **, *** mutually exclusive, highest score should be used
- •Capable of providing informed consent or has a legally authorized representative (LAR) if unable to provide informed consent
- •Willing and able to adhere to the study visit schedule
排除标准
- •Subjects meeting any of the following criteria may not be enrolled in the study:
- •Is pregnant
- •Has a systemic infection at the time of surgery (ie bacteremia)
- •Has a remote body site infection at the time of surgery (ie UTI)
- •Has a known allergy or hypersensitivity to silver, adhesive, or dressing material
- •Has a requirement for competing therapy (ie open negative pressure wound therapy)
- •Is simultaneously participating in another interventional trial
结局指标
主要结局
Deep wound infection
时间窗: within 30 postoperative days
次要结局
- Superficial Wound Infection(within 30 postoperative days)
- Wound dehiscence(within 30 postoperative days)