A Randomized Controlled Trial Comparing the Incidence of Surgical Site Infections in Cesarean Section With and Without Subcutaneous Drain Placement at Queen Savang Vadhana Memorial Hospital
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
To study and compare the incidence of surgical site infection after cesarean section in pregnant women with subcutaneous wound drainage and those without subcutaneous wound drainage at Queen Savang Vadhana Memorial Hospital, Sriracha. Chonburi Thailand
详细描述
This study is a randomized controlled trial (RCT) designed to compare the incidence of surgical site infection after cesarean section between patients who receive subcutaneous wound drainage (Radivac drain) and those who do not. Postoperative wound follow-up will be conducted on postoperative days 3, 7, and 14.
Participants will be randomly assigned into two groups, with the control group consisting of pregnant women undergoing cesarean section at Queen Savang Vadhana Memorial Hospital, Sriracha. Data will be collected on surgical site infection, pain, postoperative complications, and length of hospital stay.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Able to communicate in Thai
- •Undergoing cesarean section, both elective and emergency procedures
- •Subcutaneous fat thickness ≥ 4 cm, measured preoperatively using a standardized ultrasound technique
- •Able to return for postpartum follow-up at Somdech Phra Boromrajthevi Hospital, Sriracha
- •Willing to participate in the study and able to provide written informed consent
排除标准
- •Pregnant women with chronic immunosuppressive conditions, such as systemic lupus erythematosus (SLE), HIV infection, severe anemia (Hb < 10.0 g/dL), or uncontrolled diabetes
- •Presence of skin disease or skin infection at the abdominal surgical site
- •Evidence of infection prior to cesarean section
- •Abnormal bleeding disorders requiring specialized treatment
- •History of allergy to, or complications from, the use of wound drainage systems
- •Refusal to participate in the study
研究组 & 干预措施
Intervention group
Pregnant women undergoing cesarean section with placement of a subcutaneous wound drain.
干预措施: Radivac drain (Device)
Control group
Pregnant women undergoing cesarean section without placement of a subcutaneous wound drain.
结局指标
主要结局
Primary outcome
时间窗: 14 days
To compare the incidence of surgical site infection after cesarean section in pregnant women with and without subcutaneous wound drainage.
次要结局
- Length of hospital stay(14 days)