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
- 尚未招募
- 入组人数
- 237
- 试验地点
- 1
- 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 Inova. 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
- 否
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.
研究组 & 干预措施
Suture wound closure
Absorbable Moncryl sutures for closure of cesarean skin incision
干预措施: Subcuticular monocryl suture (Procedure)
Absorbable staple wound closure
Staples will be applied as per the manufacturer's instructions intraoperatively using INSORB device manufactured by CooperSurgical.
干预措施: Subcuticular absorbable staple using Insorb device (Device)
结局指标
主要结局
Operating time
时间窗: Time from the start of surgery through end of skin closure up to 8 hours
Total time for the procedure
次要结局
- Wound Cosmesis(Up to six weeks post partum)
- Post Operative Pain(up to 3 days post-operatively)