Staples Compared With Subcuticular Suture for Skin Closure After Cesarean Delivery in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Wound complication rates
研究概览
简要总结
This is a randomized prospective clinical trial designed to determine the wound complication rates for stainless steel staples versus subcuticular suture for skin closure in the obese parturient (BMI≥ 30kg/m2) undergoing cesarean delivery.
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
- None
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 years or older
- •BMI ≥ 30kg/m2 on admission to labor and delivery
- •Patient is for scheduled cesarean delivery or in non-emergent labor but has an indication for cesarean delivery
- •Singleton pregnancies
- •Gestational age ≥ 24weeks
- •Cesarean delivery performed under regional anesthesia
排除标准
- •Refusal to participate
- •BMI < 30kg/m2
- •< 24 weeks gestation
- •Intrauterine fetal demise
- •Chronic pain syndrome requiring chronic narcotic use
- •Emergent clinical situations which preclude obtaining informed consent
研究组 & 干预措施
Arm 1: Skin closure with suture
Subjects in this group will be randomized to suture for skin closure with computer generated random card draw.
干预措施: Suture vs. staples closure method after c-section in obese women. (Procedure)
Arm 2: Skin closure with staples
Subjects randomized to skin closure with staples with computer generated random card draw.
干预措施: Suture vs. staples closure method after c-section in obese women. (Procedure)
结局指标
主要结局
Wound complication rates
时间窗: 6 weeks postpartum
Wound complications will be classified as minor and major and the major complications will be further stratified as Seroma, Hematoma and Wound Infection/Surgical site infection (SSI). 1. Minor wound disruption: any wound disruption that DOES not require that the incision be opened, evacuated, irrigated or debrided. There is no evidence of infection including erythema, induration or purulent material. No antibiotic therapy is given. 2. Major wound disruption requires that incision be opened, evacuated, and or irrigated or debrided and includes: * Seroma: collection of serous fluid in the wound without evidence of infection * Hematoma: Demonstrable blood clot between the rectus fascia and the skin * Infection: Any wound that drains purulent material and shows at least 2 of the classic signs of infection; induration, erythema, tenderness, fever. Wound infections will be further classified as superficial or deep.
次要结局
- Post-operative pain(72 hours postpartum)