Subcuticular Absorbable Staples Versus Conventional Skin Closure in Women Undergoing Cesarean Delivery: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Operating Time
研究概览
简要总结
Despite the high numbers of cesareans being performed, scientific evidence behind which surgical techniques are best remains uncertain. Our objective is to determine if subcuticular absorbable staples improve operative time and wound cosmetics.
详细描述
This will be an open-label randomized controlled clinical trial. Women undergoing cesarean delivery will be randomized to have either standard wound closure with Monocryl suture or absorbable subcuticular staples placed by INSORB skin stapling device. The INSORB under the skin stapling device is FDA approved but not currently used as standard of care at UTMB. We will exclude women with intraamniotic infection, immunosuppression, active skin infection, those unlikely to be followed-up after delivery, or unable to provide consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Reviewers of wound cosmetics during the post operative time will be blind to the intervention. However, surgeon at the time skin closure and patient will not be blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18-50 years of age
- •Women ≥ 24 weeks viable gestation
- •Will be undergoing cesarean delivery
排除标准
- •Patient unwilling or unable to provide consent.
- •No or very limited prenatal care or a non-resident patient who is unlikely to follow-up after delivery.
- •Immunosuppressed subjects: i.e., taking systemic immunosuppressant or steroids (e.g. transplant subjects; not including steroids for lung maturity), HIV with CD4 <200, or other
- •Decision not to have skin closure (e.g. secondary wound closure, mesh closure)
- •Current skin infection
- •Coagulopathy
- •High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, tubal ligation, bowel or adnexal surgery)
- •Incarcerated individuals
- •Intraamniotic infection
- •Subjects participating on other treatment trials or studies that would interfere with the current study's primary outcome.
结局指标
主要结局
Operating Time
时间窗: Start of surgery through end of skin closure in minutes
Total time for the procedure
次要结局
- Use of Resources(Time of surgery through six weeks post partum)
- Post Operative Pain(5-10 days)
- Skin Closure Time in Minutes(Time of surgery through six weeks post partum)
- Wound Cosmesis(Time of surgery through six weeks post partum)
- Number of Adverse Events(Time of surgery through six weeks post partum)
- Number of Participants With Composite Wound Complication(Time of surgery through six weeks post partum)