Closure of Skin in ChorioAmnionitis Research Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Patient recruitment rate
研究概览
简要总结
The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.
The investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate > 100bpm, Fetal tachycardia: Baseline heart rate > 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count > 15,000 cells/mm3)
- •Caesarean delivery with Pfannenstiel incision
- •Pregnancies >24 weeks
- •Scheduled or non-elective procedures
- •Primary or repeat Caesarean delivery
- •No restrictions based on BMI
- •No exclusions due to DM (GDM or non GDM)
- •No exclusions due to multiple gestation pregnancy
排除标准
- •Non-Pfannenstiel incision
- •Immune compromising disease
- •History of keloid formation
- •Chronic steroid use
- •Allergy to staples
- •Planned postpartum care at another facility
结局指标
主要结局
Patient recruitment rate
时间窗: 1 year
The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.
次要结局
- Wound disruption(6 months post-operative)
- Wound cosmesis(6 months post-operative)
- Follow-up rates(6 months post-operative)
- Wound infection(6 months post-operative)
- Patient satisfaction(6 months post-operative)
- Participation rate(1 year)
研究者
Ellen Giesbrecht
Principle Investigator
University of British Columbia