The SAVIOR Trial: Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
研究概览
简要总结
The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.
详细描述
In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.
The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.
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
- Single (Care Provider)
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
- •Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.
- •Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.
- •Patient with BMI≥ 30 at the time of surgery
- •Patient agrees to return for all required clinical follow up for the study.
排除标准
- •Known allergic reaction to acrylic adhesives or silver.
- •Known history of intolerance to any component of Prevena Incision Management System TM.
- •Very fragile skin around incision site.
- •Bleeding disorder or refuses blood transfusion.
- •Malignancy or other condition limiting life expectancy to <5 years.
- •Pregnancy
研究组 & 干预措施
Prevena
After surgery this group will receive the Prevena device (negative pressure wound therapy).
干预措施: Prevena (Device)
Standard dressing
After surgery this group will receive standard of care dressings on their surgical wound.
干预措施: Standard Dressing (Device)
结局指标
主要结局
Surgical Site Infection According to National Healthcare Safety Network - Center for Disease Control Guidelines
时间窗: Up to 7 days postop
The incidence of postoperative surgical site infection (according to National Healthcare Safety Network - Center for Disease Control guidelines) in open surgery
次要结局
- Energy / Fatigue as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- Social Functioning as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- Emotional Well Being as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- Other Wound Complications (Aggregate)(Up to 14 days postop)
- Physical Function as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- Skin Bacterial Count as Assessed by Microbacterial Count(Up to 7 days postop)
- Readmissions(Up to 30 days postop)
- Role Limitations Due to Physical Health as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- Pain as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)
- General Health as Assessed by Short Form Survey (SF) 36(Up to 14 days postop)