跳至主要内容
临床试验/NCT06237855
NCT06237855终止不适用

Empowering Patients: A Randomized Controlled Trial (RCT) Investigating the Feasibility and Outcomes of Patient Self-Drain Removal After Ventral Hernia Repair

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2024年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
11
试验地点
2
主要终点
Success rate of patients self-removing drains

研究概览

简要总结

The goal of this randomized controlled trial is to teach patients to safely and effectively self-remove drains at home in adults (aged 18 and older) following a ventral hernia repair (VHR). Researchers will compare the group of subjects self-removing the drain at home to a control group of standard of care drain removal during a clinic visit by a provider to see if subjects are able to safely self-remove the drain at home.

详细描述

Annually, in the United States, it is estimated that 500,000 ventral hernia repairs (VHRs) are performed with a cost in excess of $3.2 billion. Drains are frequently used in an effort to prevent seroma formation. Seromas are defined as a buildup of bodily fluid in a potential space post-surgery, usually at the surgical site. Rate of seroma has been estimated to be between 9-11% following abdominal wall reconstruction (AWR). The timing of the removal is usually after discharge but before patient's scheduled postoperative visit, thus most patients must call and speak to a health provider and come in for an additional clinic visit specifically for drain removal. The goal of this study is to teach patients to safely and effectively self-remove drains at home. This will allow patients to forgo the cost associated with commuting to the clinic, the clinic cost associated with nursing time and scheduling, the clinic visit, physician or nurse time to remove the drain and possibly lost wages for the patient from time off work. It is important to note that self-drain removal will not compromise or deviate from typical patient follow up. Instead, this will eliminate an extra patient visit when inevitably the timing of drain removal does not align with the typical follow-up period. Additionally, this will allow providers to see additional patient consultations or perform other duties, as they will not have the time constraints associated with in-office drain removal. This study will show that patient self-drain removal benefits the patients, the providers, and healthcare system without compromising patient safety, satisfaction, and postoperative care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Aged ≥18 years.
  • Undergoing elective ventral hernia repair (VHR).
  • Sub-cutaneous drain placement.
  • Anticipated Centers for Disease Control and Preventions (CDC) 1&2 wound class.

排除标准

  • Patients who do not have access to the online training video.
  • The surgeon does not believe the patient can self-remove the drain.
  • Planned concomitant procedures.
  • Current mesh infection.

结局指标

主要结局

Success rate of patients self-removing drains

时间窗: 2 weeks post-operatively

Percentage of patients that are able to safely self-remove drain at home.

次要结局

  • Post-drain removal satisfaction survey scores(30-days post-operatively)
  • Wound complication rate(30-days post-operatively.)
  • Difference In Subject Costs(30-days post-operatively)
  • Difference in Subject Amount of Time(30-days post-operatively)
  • Change in drain removal training survey scores from pre to post training(Hour 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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