Incidence of Surgical Site Infection in Perforated Appendicitis After Peritoneal Lavage With Super-oxidised Solution: A Randomised Double-blind, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
This study is to evaluate the effectiveness of peritoneal lavage with super-oxidised solution in reducing surgical site infection after open surgery for perforated appendicitis.
详细描述
Open appendicectomy for perforated appendicitis is associated with significant morbidity from surgical site infection. The standard practice is to perform peritoneal and wound lavage using normal saline solution. The investigators propose the use of superoxidized solution for peritoneal and wound lavage to decrease the incidence of surgical site infection.
Superoxidized solutions contain hypochlorous acid (HOCl) which has bactericidal properties. The reactive oxygen species that is produces damages cell wall membrane of unicellular organisms, however remains safe when in contact with human or animal tissue. It is commonly used for topical treatment of wounds.
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
The study participants, healthcare providers who attend to the participants during the trial (surgeon and nurses), outcome evaluators (surgical doctors and nurses) and data collectors will be blinded to the allocation.
The sterile study solution (super-oxidised solution) or placebo (normal saline 0.9%) will be stored in a similar storage container and will have the same clear appearance.
入排标准
- 年龄范围
- 13 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age 13 and 70 years
- •Diagnosed with perforated appendicitis intra-operatively
- •Undergo open appendicectomy via Lanz incision
排除标准
- •Surgical technique: Laparoscopic appendicectomy or mid-line laparotomy
- •Patients on steroid treatment and immunosuppressant therapy.
研究组 & 干预措施
Super-oxidised Solution
Peritoneal lavage with super-oxidised solution of at least 10 cc/kg and wound lavage with super-oxidised solution 1 cc/kg
干预措施: Superoxidized Water (Drug)
Normal Saline
Peritoneal lavage with normal saline 0.9% of at least 10 cc/kg and wound lavage with normal saline 0.9% 1 cc/kg
干预措施: Normal Saline (Drug)
结局指标
主要结局
Surgical site infection
时间窗: 30 days post surgery
Number of participants with surgical site infection after open surgery for perforated appendicitis
次要结局
- Post-operative Ileus(From end of surgery till first passage of flatus or bowel opening, whichever comes first, assessed up to 30 days)
- Inflammatory marker C-reactive protein(24 and 48 hours post surgery)