跳至主要内容
临床试验/NCT06063629
NCT06063629Unknown不适用

Roles of Prophylactic Subcutaneous Drain in Preventing Surgical Site Infection in Abdominal Surgery Wound Class III and IV

Queen Savang Vadhana Memorial Hospital, Thailand0 个研究点目标入组 180 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
主要终点
Rate of Surgical Site Infection (SSI)

研究概览

简要总结

Surgical site infections (SSI) pose a common challenge in the field of surgery. Current evidence and literature do not provide clear consensus whether the use of subcutaneous drainage will help reduce the incidence of SSI in patients who underwent abdominal surgery, especially in wounds that are categorized as contaminated (class 3) or dirty/infected (class 4).

The objective of this clinical study is to compare the rate of surgical site infection in contaminated and dirty/infected surgical wounds among patients whose wounds are inserted with subcutaneous drainage and patients who are not inserted with subcutaneous drainage.

详细描述

This study is a randomized, controlled and open study, where participants who undergo abdominal surgery will be randomly allocated into two groups: (i) patients whose wounds are inserted with subcutaneous negative pressure drain and (ii) patients whose wounds are not inserted with subcutaneous negative pressure drain.

The participants in this study will know the details about the presence of their drain placement after the operation. If the patient was assigned to the drain group, the drain will be placed for five days or until there are no content observed in the drain. The primary outcome of this study is the occurrence of SSI, which will be tracked up to 30 days post-operation. The patient in both groups will also be evaluated by the surgeons at day 3, 5, 7, 14 and 30 post-operation for signs and complications of SSI. In situation where the patients are discharged prior to the date of evaluation, the patients will be scheduled for evaluation during the follow-up visits.

If SSI is detected in the drain group prior to removal, the drain will be removed and the patient will be treated with wet dressing combined with antibiotics. Complications of SSI will also be noted. Patient's data on demographic, medical history, clinical presentation, details of operation, and other laboratory findings will also be collected to investigate for risk factors for development of SSI between each group.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age equal or over 18 years old
  • Admitted to Queen Savang Vadhana Memorial Hospital
  • Receive abdominal surgery and were classified as class 3 or 4 wound

排除标准

  • Patients who undergo operation for ostomy
  • Patients who do not receive appropriate antibiotics
  • Patients who undergo operation before full recover of prior operation
  • Patients who undergo laparoscopic operation
  • Pregnant women
  • Patients who had history of prior radiation therapy at abdomen
  • Patient with immunocompromised status
  • Patient with chronic skin disease

结局指标

主要结局

Rate of Surgical Site Infection (SSI)

时间窗: Post operation day 30

The rate of SSI will be compared between the drain and no drain group

次要结局

  • Length of hospital stay(Post operation day 30)

研究者

发起方
Queen Savang Vadhana Memorial Hospital, Thailand
申办方类型
Other
责任方
Sponsor

相似试验