Impact of Surgical Site Infection in Peritonitis After Peritoneal Lavage With Super-oxidixed Solution: A Randomised Double-Blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 116
- 主要终点
- SSI Incidence
研究概览
简要总结
This is randomised double blinded placebo-controlled parallel-group study. Patients in Hospital Queen Elizabeth, Sabah and Hospital Universiti Sains Malaysia, Kelantan who undergo laparotomy for peritonitis will be equally randomised into two groups : intervention group receiving super-oxidised solution and the control group receiving normal saline during peritoneal and wound lavage.
This is a superiority study assessing the effectiveness of the intervention. The patient and doctors directly involved in the partient care will be blinded in this study
详细描述
OBJECTIVES
PrimaryOutcome:
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for peritonitis.
SecondaryOutcome:
i.To evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing inflammatory markers C-reactive protein(CRP) at 24 and 48 hours after open surgery for peritonitis ii.To evaluate the effectiveness of peritoneal lavage with super oxidised solution in reducing duration of post-operative ileus after open surgery for peritonitis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
computerized block randomization using the website www.randomization.com with a block size of 8 and allocation ratio of 1:1
入排标准
- 年龄范围
- 13 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 13yrs and above
- •Diagnosed with perforated viscus intraoperatively
- •Undergo Midline Laparotomy
- •ASA 3 and below
排除标准
- •Surgical technique: Laparoscopic washouts
- •Patients on steroid treatment and immunosuppressant therapy.
- •More than ASA 3
- •Inability to give/understand informed consent
- •Revision-surgery (previous abdominal surgery within the last 30 days)
- •Planned re-laparotomy within 30 days
- •Terminal kidney failure requiring dialysis
- •Concurrent abdominal wall infections
研究组 & 干预措施
Control group
Peritoneal lavage with normal saline 0.9% 1L and wound lavage with normal saline 0.9% 500ml
干预措施: Normal Saline (Device)
Study group
Peritoneal lavage with super-oxidised solution of at least 1L and wound lavage with super-oxidised solution of 500ml
干预措施: Hydrocyn Aqua® (Device)
结局指标
主要结局
SSI Incidence
时间窗: 30 days
To evaluate the effectiveness of peritoneal lavage with superoxidised solution in reducing incidence of surgical site infection after open surgery for perforated viscus.
次要结局
- Flatus time(1-2 days)
- CRP Level(24-48 hrs)
研究者
Dinesh Alagoo
Dr
Universiti Sains Malaysia