Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 8
- 主要终点
- Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
研究概览
简要总结
The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.
详细描述
A. To assess the rate of wound complications with staples versus subcuticular suture closure in women with a BMI of ≥ 40 kg/m2 undergoing cesarean delivery (CD).
B. No difference was observed in wound complication rates between staples and subcuticular suture skin closure in women with a BMI ≥ 40 kg/m2 undergoing cesarean delivery (CD).
C. At this time, optimal skin closure method in obese women with BMI ≥ 40 kg/m2 undergoing cesarean delivery remains unknown. More work is needed in this area to help reduce the complication rate in this very high-risk population.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women > 18 years old undergoing cesarean delivery (CD)
- •BMI of >/= 40 kg/m2 as determined by height and weight reported during their admission
- •Live gestation 23 weeks or greater
- •Women who are able to follow-up 7-14 days after hospital discharge for a visual wound check.
排除标准
- •Active lupus flare
- •Current treatment for cancer or h/o radiation to the abdomen/pelvis
- •Hypersensitivity to steri-strips
结局指标
主要结局
Composite Wound Complication at Hospital Discharge and 2 Weeks Postpartum
时间窗: At hospital discharge, at 2 weeks postpartum and at 6 weeks postpartum
Rate of wound complications defined as composite wound complication, which includes infection requiring antibiotics, hematoma, seroma, separation or disruption, and/or readmission to the hospital for wound concerns.
次要结局
- Number of Participants With Blood Transfusion(At time of surgery and hospitalization)
- Number of Participants Receiving Postpartum Prophylactic Anticoagulation(During hospitalization)
- Patient Pain Score (From 1 to 10)(Within 2 weeks postpartum)
- Number of Participants With 5 Minute Apgar Score <7(At time of delivery)
- Total Length of Hospital Stay(At time of surgery and hospitalization)
- Number of Participants According to Skin Incision(At time of surgery and hospitalization)
- Operating Surgeon Level(At time of surgery)
- Surgical Assistant Level(At time of surgery)
- Change in Hemoglobin (Pre-delivery and Post-delivery)(At time of surgery (pre-delivery) and post-delivery)
- Patient Satisfaction With Wound Healing and Appearance(At time of hospital discharge and at 2 weeks postpartum)
- Total Operative Time(At time of surgery and hospitalization)
- Total Blood Loss(At time of surgery)
- Neonatal Birthweight(At time of delivery)
研究者
Jennifer McNulty, MD
Maternal Fetal Medicine Specialist
MemorialCare Health System