NCT01217567已完成不适用
Subcuticular Suture Versus Staples for Closure of the Skin After Caesarean Section: A Prospective Randomized Single-blinded Case-Control Study With the Case as it's Own Control.
Holbaek Sygehus2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Preferred side of the caesarean section scar
研究概览
简要总结
The Purpose of this study is to compare two methods for closure of the skin after caesarean section on the same patient; staples and subcuticular sutures. The study is performed on two separate groups of patients: 1. Woman having cesarean section for the first time and have not previously had abdominal surgery through a lower abdominal transverse incision. 2. Woman, who have previously had a caesarean section done. The following parameters are registered:
- An objective evaluation of the two ends of the scar 6 months postoperatively.
- A patient evaluation of the two ends of the scar 6 months postoperatively.
- The difference in pain in the two ends of the scar 1 day postoperatively (blinded).
- The difference in pain in the two ends of the scar 7 days, 3 and 6 months postoperatively.
- The rate of infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 是
入选标准
- •Woman having elective or level III caesarean section. Level III caesarean section is defined as being ordered more than 30 minutes before surgery is started.
- •Woman who speak and understand Danish
- •Woman who can give informed consent.
排除标准
- •Level I or II caesarean section (ordered less than 30 min. before surgery is started).
- •Diabetics (this does not include gestational diabetes).
- •Infection
- •Regular treatment with immunosuppressives
- •Alcohol or drug abuse
- •Age under 18
- •Chronic pain disease eg fibromyalgia, rheumatoid arthritis
- •BMI over 35
- •Previous abdominal surgery through lower transverse abdominal incision (only applicable to woman having caesarean section for the first time).
结局指标
主要结局
Preferred side of the caesarean section scar
时间窗: 6 months postoperatively
Preferred side of the scar and thereby method for closure of the skin: Staples, subcuticular suture or no difference.
次要结局
- The difference in pain between the two ends of the scar(3 and 6 months postoperatively)
- Pain in the two ends of the scar(3 and 6 months postoperatively)
- Infection(3 and 6 months postoperatively)
- Cosmetic objective evaluation of the two ends of the scar(6 months postoperatively)
- Comparison of outcome measures in woman with no previous abdominal surgery and woman with previous caesarean section.(6 months)
研究者
Anna Aabakke
Anna Aabakke, M.D.
Holbaek Sygehus
研究点 (2)
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