Role of Perioperative Hyperoxygenation in Wound Infection Following Surgery for Acute Appendicitis: A Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- ASEPSIS Score
研究概览
简要总结
The study evaluates the role of supplemental hyper-oxygenation given perioperatively on wound site infection after appendectomy. Half of the patients received ≥50% oxygen and half of them received no oxygen during the surgical procedure.
详细描述
Patient with the diagnosis of acute appendicitis of >15 years of age group, with no comorbidities who presented to surgical emergency in Dr. Ram Manohar Lohia Hospital were considered for the present study.
30 patients who fulfilled the inclusion criteria and who voluntarily consented for the study were randomly allocated to the two groups- Group A (control group) and Group B (study group).
These patients were operated through Mc-Burney incision given in the right lower quadrant.
Both the groups were comparable in their demographic and preoperative profile. The study group was given ≥50% of oxygen intraoperatively and the control group was given no oxygen.
In postoperative period, oxygen was given to group A at the rate of 4 litre/minute (L/min) and group B at the rate of 6 litre/minute (L/min).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis or Radiological diagnosis of acute appendicitis.
- •Appendectomy through the Mc Burney incision.
排除标准
- •Patients with chronic obstructive pulmonary diseases.
- •Immunodeficiency disease.
- •Patients requiring midline incision.
- •Patients requiring general anaesthesia after failure of spinal anaesthesia.
- •Patients requiring higher oxygen in perioperative period.
研究组 & 干预措施
Group B: Test
Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.
干预措施: oxygen (Drug)
结局指标
主要结局
ASEPSIS Score
时间窗: 14 days
ASEPSIS score- Additional treatment; Serous discharge; Erythema; Purulent exudate; Separation of deep tissues; Isolation of bacteria; and Stay. A daily score of 20 or more considered evidence of infection. Category of infection: Total score of 0-10 satisfactory healing; 11-20 disturbance of healing; 21-30 minor wound infection; 31-40 moderate wound infection; \> 40 severe wound infection.
次要结局
- Number of Patients Requiring Additional Investigations(14 days)
- Number of Patients Requiring Additional Treatment(14 days)
研究者
Swati Sattavan
Senior Resident
Lady Hardinge Medical College