A prospective randomised controlled trial investigating the role of subcutaneous suction drain in the prevention of superficial surgical-site infection followng median laparotomy in gynecological oncosurgery.
试验速览
- 阶段
- 不适用
- 状态
- Other
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- The incidence of superficial surgical site infection as defined by Center for Disease Control and Prevention.
研究概览
简要总结
| This is a prospective randomised controlled trial on patients who underwent elective laparotomy for suspected or confirmed gynaecological cancer at a gynaecologic oncosurgical unit of a tertiary cancer centre in South India. Patients who underwent surgery through a midline vertical incision with subcutaneous fat thickness >2cm were included in the trial. They were randomised into two arms: the drain arm and the no-drain arm. A subcutaneous closed suction drain was used in the drain arm. The primary outcome measured was the incidence of superficial surgical site infection (s-SSI) as defined by Centers for Disease Control and Prevention. |
The study was scheduled to conclude after 15 months. The sample size calculated was 390 patients. However, even after 18 months the required sample size could not be achieved and the study was terminated. 528 patients were screened for the study. Among those who gave informed consent, 308 patients were recruited based on the inclusion and exclusion criteria
303 patients were available for final analysis, of which 146 were in the ‘drain arm’ and 157 were in the ‘no drain arm’. Overall, 31 patients (10.2%) developed s-SSI. Although the s-SSI incidence was higher in the no- drain arm compared to the drain arm (13.4% versus 6.8%), the difference was not statistically significant (p: 0.087).
In the subgroup of 47 patients with subcutaneous fat thickness >5 cm, only 1 (4%) patient in the drain arm developed s-SSI, as compared to 9 (40.9%) in the no-drain arm (p value - 0.003). This difference is statistically significant, with subjects in the drain arm 0.06 times likely to develop s-SSI as compared to those in the no-drain arm (OR(95% CI): 0.06 (0.001-0.54)).
This study reveals that subcutaneous suction drains are beneficial in preventing s-SSI only among subjects with subcutaneous fat thickness greater than 5 cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 14.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients undergoing elective laparotomy by midline vertical incision for confirmed or suspected gynecological cancer.
- •Subcutaneous fat thickness >2cm, as measured intra-operatively.
排除标准
- •Immediate re-laparotomy -Mesh repair.
- •Clean wounds.A clean wound is an uninfected operative wound in which no infl ammation is encountered and the respiratory,alimentary,genital,or uninfected urinary tract is not entered. In addition, clean wounds are primarily closed and, if necessary,drained with closed drainage..
结局指标
主要结局
The incidence of superficial surgical site infection as defined by Center for Disease Control and Prevention.
时间窗: 30 days
次要结局
未报告次要终点