To Investigate the Incidence of Surgical Site Infection in Low Risk Women Having a First Time Planned Caesarean Section Using the Alexis O Retractor and the Traditional Metal Retractor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor.
研究概览
简要总结
Objective:
To investigate if the use of the newly designed Alexis O Retractor leads to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections.
Study Design:
This ethically approved study is designed as a prospective, randomized controlled trial in planned, first time Caesarean Sections with 200 patients randomized to either the Alexis-O Retractor group or the conventional group. Patients with wound healing problems, connective tissue disorders, insulin dependent diabetes, bleeding disorders, previous major abdominal surgery and chorioamnionitis are excluded. Outcomes include surgical site infection, intraoperative parameters such as tissue damage, postoperative analgesia requirements and patient satisfaction scores.
详细描述
Main Hypothesis:
Does the use of the newly designed Alexis O Retractor lead to improved Surgical Site Infection rates intra-operative and post-operative surgical outcomes in the setting of planned elective first time Caesarean Sections in patients compared to the traditional self-retaining metal retractor?
Secondary Hypotheses:
Does the Alexis O Retractor lead to improved intra-operative and post-operative surgical outcomes in the setting of planned elective Caesarean Sections?
Study Design:
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Elective Caesarean Section
- •First Caesarean Section
- •Exclusion Criteria
- •Chronic auto immune diseases
- •Immune deficiency diseases
- •known bleeding disorders
- •full anti-coagulation therapy
- •wound healing problems
- •previous Caesarean Section
- •major abdominal surgery
- •laparotomy
- •active phase of labor
- •suspected chorioamnionitis
- •confirmed chorioamnionitis
排除标准
- 未提供
结局指标
主要结局
Incidence of surgical site infection in low risk women having a first time planned Caesarean Section using the Alexis O Retractor compared to the traditional Metal Retractor.
时间窗: 6-8 Weeks after Surgery
次要结局
- Visual Field Satisfaction Scores(On the day of Surgery (Day 0))
- Application Satisfaction Scale Scores(Immediate Postoperative)
- Removal Satisfaction Scale Scores(On the day of Surgery (Day 0))
- Post Operative Pain Scale Scores at Discharge(On the day of discharge (3-5 days))
- Post Operative Pain at 6 Weeks(6 weeks post operative)
- Patients with Wound Dehisence at Discharge(On the day of discharge (3-5 days))
- Patients with either open wounds, infected wounds, bleeding wounds or painful wound at 6 Weeks(6 weeks post operative)
- Blood Loss Volume(On the day of Surgery (Day 0))
- Freedom of Movement Satisfaction Scores(On the day of Surgery (Day 0))
- No. Patients with Prolapsing Bowel in the operative field at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients needing repositioning of prolapsing bowel at the time of Caesarean(On the day of Surgery (Day 0))
- No. of Patients with bowel injury sustained at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients sustaining bladder injury at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients where bowel packing with abdominal swabs was performed at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients where suction of Blood and Liquor from the parabolic gutters was necessary at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients where the Uterus was exteriorized at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients with Rectus Sheath Fascial Tears at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients with Rectus Muscle Tearing at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients where Rectus Muscle Suturing was performed at the time of Caesarean(On the day of Surgery (Day 0))
- No. of Patients where Subcutaneous Electro-Coagulation was performed at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients with lacerations to the skin wound edges at the time of Caesarean Section(On the day of Surgery (Day 0))
- No. of Patients where the Baby was cut at the time of Caesarean Section(On the day of Surgery (Day 0))
- Wound Healing Satisfaction at 6 Weeks(6 weeks post operative.)
- Time to Discharge(3-5 Days)
研究者
Larry Hinkson
Consultant in Obstetrics
Charite University, Berlin, Germany