Post-Operative Cosmesis and Skin Closure Methods After Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- scar cosmetic score
研究概览
简要总结
Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Several recent reviews have summarized the evidence for various steps of cesarean delivery, but surprisingly in many cases there is little scientific evidence on which to base the choice of surgical technique.
详细描述
Cesarean delivery is the most common surgical procedure performed in the United States, with over 1 million procedures performed per year. Based on recent Center for Disease Control (CDC) National Vital Statistics Report (2021) 32.1% of all births in the United States were via cesarean delivery. Given the high numbers of cesarean deliveries being performed today, there has been interest in optimizing surgical techniques. Absorbable staples, made from a combination of polylactic and polyglycolic acid, are a relatively new option for skin closure at the time of surgery. This study is a randomized trial that will investigates two cesarean skin closure techniques-subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples (INSORB)-to determine if one is associated with better scar cosmesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Scars will be digitally photographed by study staff and scored by 2 independent judges. The judges will be blinded to the closure method at time of scar evaluation.
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-44
- •Any parity
- •Scheduled cesarean section
- •Neuraxial analgesia
排除标准
- •Non-English Speaking
- •Incarcerated
- •Maternal Connective Tissue Disorder
- •Systemic maternal steroid use
- •Three prior cesarean deliveries
- •Body Mass Index (BMI) >40
研究组 & 干预措施
subcuticular absorbable polyglycolic acid (INSORB) staples
Insorb absorbable staples are used for skin closure
干预措施: absorbable subcuticular polyglycolic acid staples (INSORB) (Procedure)
subcuticular absorbable polyglecaprone suture (Monocryl)
Monocryl absorbable staples are used for skin closure
干预措施: subcuticular, polyglecaprone suture (Monocryl) (Procedure)
结局指标
主要结局
scar cosmetic score
时间窗: Week 6
Scars will be digitally photographed by study staff and scored by 2 independent judges (attending Obstetricians) according to the SCAR scale validated by Kantor with scores ranging from 0 (best) to 15 (worst).
次要结局
- amount of in-hospital oral opiate analgesic use(Week 6)
- Number of Wound complications(Week 6)
- length of hospital stay(Week 6)
- amount of in-hospital oral NSAID analgesic use(Week 6)
- patient rated subjective pain score(Week 6)
- patient's overall satisfaction with cosmesis scores(Week 6)
- amount of in-hospital intravenous opiate analgesic use(Week 6)