跳至主要内容
临床试验/NCT02071251
NCT02071251已完成2 期

A Study to Evaluate a Quality Improvement Intervention to Reduce Wound Separation Rates in Obese Gynecologic Oncology Service Patients Undergoing Abdominal Surgery

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
105
试验地点
2
主要终点
Wound complication

研究概览

简要总结

Approximately 500,000 surgical site infections occur annually in the US. These lead to worse patient quality of life, more outpatient and emergency room visits, readmissions and home services, with an estimated increase in costs of at least $3500 per complication. Surgical site infections are associated with increasing body mass index. There is limited and conflicting data of the utility of multiple surgical interventions to decrease the risk of surgical site complications. The investigators explored the effect of a prospective care pathway for closure of vertical abdominal wounds on patient's wound complications.

研究设计

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

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women were eligible if they were between the ages of 18-89, with a BMI ≥ 30 kg/m2 undergoing a gynecologic procedure via a vertical abdominal incision. -

排除标准

  • Planned laparoscopic surgery, planned panniculectomy or other plastic surgery procedure at the time of laparotomy, prior history of hernia repair with mesh or planned mesh hernia repair at the current procedure, enterotomy or intestinal surgery, a history of prior radiation to the abdomen or pelvis, concurrent pregnancy, current incarceration, or inability to provide informed consent, including inability to understand spoken English.

结局指标

主要结局

Wound complication

时间窗: Within 8 weeks of surgery

The primary outcome for our study was a wound complication within eight weeks of laparotomy. Wound complication was defined as seroma, hematoma, separation, or infection requiring additional medical and/or surgical management within eight weeks of laparotomy.

次要结局

  • Wound infection(8 weeks of surgery)
  • Wound separation(8 weeks of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

A Study to Evaluate a Quality Improvement... | 临床试验