跳至主要内容
临床试验/NCT02390401
NCT02390401终止1 期

Incisional VAC at Cesarean Section for Prevention of Post Operative Wound Complications in the Obese

Dartmouth-Hitchcock Medical Center8 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
入组人数
166
试验地点
8
主要终点
Post-operative wound infection

研究概览

简要总结

To study if incisional vacuum-assisted closure can decrease the risk of infection in cesarean section incisions in the obese compared with standard sterile dressing.

详细描述

The prevalence of obesity (defined as body mass index (BMI, kg/m2) ≥ 30) has significantly increased, affecting approximately 35% of adult females in the United States, according to CDC 2009-2010 statistics. Obesity has a significant impact on pregnancy, including increased need for cesarean section and post-operative wound complications. Infection rates have been reported to be between 10 and 30%. The advent in 1997 of negative pressure therapy (NPT), also known as vacuum assisted closure (VAC), has vastly changed wound care management. Briefly, VAC has been traditionally applied to a chronic wound to create negative or sub-atmospheric pressure, thus promoting wound healing by decreasing edema and increasing blood flow and formation of granulation tissue. Use of this therapy at the time of primary closure of a surgical incision (first trialed in 2006 and termed "Incisional VAC") has provided a promising approach to reducing post-operative wound infection. Incisional VAC has been explored primarily in the orthopedic and cardiothoracic fields, but very few studies have examined the use on abdominal incisions, and only one to date on cesarean section incisions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients that have undergone cesarean section for delivery; have a BMI greater or equal to
  • All cases of cesarean section including primary and repeat, scheduled and urgent.

排除标准

  • Patients who deliver vaginally; age less than 18 years old; silver allergy; non-English speaking

研究组 & 干预措施

Standard sterile dressing

Active Comparator

Standard sterile dressing

干预措施: Standard sterile dressing (Device)

Vacuum-assisted closure (VAC)

Experimental

Prevena (VAC) device

干预措施: Vacuum-assisted closure (Device)

结局指标

主要结局

Post-operative wound infection

时间窗: 6 weeks post-operative

Determine number of post-operative wound infections

次要结局

  • Readmission for infection(6 weeks post-operative)
  • Rate of hematoma(6 weeks post-operative)
  • Rate of seroma(6 weeks post-operative)
  • Re-operation(6 weeks post-operative)
  • Antibiotic treatment(6 weeks post-operative)
  • Deep and superficial infection(6 weeks post-operative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zachary Spalding

Physician-Resident

Dartmouth-Hitchcock Medical Center

研究点 (8)

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