Closure of Pfannenstiel Skin Incisions After Cesarean Delivery: A Comparison of Metallic Staples Versus Absorbable Staples
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Post Operative Pain (3 Days Post-op)
研究概览
简要总结
The purpose of the study is to compare post operative pain, cost effectiveness, speed of closure and patient satisfaction of Pfannenstiel incisions closed with metallic staples versus absorbable staples (Insorb) after Cesarean Delivery.
详细描述
The ideal method of closing the skin following a Pfannenstiel incision has not yet been established. Presently, the method of skin closure is a matter of the surgeon's personal preference. Currently, there is limited evidence regarding which method is considered "superior" in terms of post operative pain, patient satisfaction, and cost effectiveness. This information would be incredibly valuable in helping guide surgeons in their choice of skin closure technique; and with the rates of Cesarean deliveries rapidly rising, it is important to determine the best method of skin closure in order to optimize patient care.
After a patient is consented she will be randomized into either the control group and receive the standard metallic staples or the experimental group and receive the absorbable staples for her skin closure procedure. One day after her procedure the RN will ask the patient to rate her pain using a 10cm VAS pain scale. Two or three days after the skin closure and before the patient is discharged a short survey about the patient's satisfaction of her scar appearance will be administered. The PI will go back and review the patient's chart to determine the amount of narcotics administered.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Obstetric service patients (receiving prenatal care from the Faculty Medical Center)
- •Women greater than 18 years old
- •Singleton gestation
- •Cesarean Section performed by Pfannenstiel skin incision
排除标准
- •History of drug or alcohol abuse
- •Contraindication to post operative NSAID's or Narcotics
- •Emergent Cesarean Deliveries
- •Less then 18 years of age
研究组 & 干预措施
Control Group
This group will receive the standard metallic staples to close their incision.
干预措施: Insorb absorbable staples (Device)
Case Group
This group will receive the Insorb absorbable staples to close their incision.
干预措施: Insorb (Device)
结局指标
主要结局
Post Operative Pain (3 Days Post-op)
时间窗: 1 Year
Post operative pain at the time of discharge will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
Post Operative Pain
时间窗: 1 Year
Post operative pain at post operative day #1 will be measured using the Visual Analogue Scale (VAS). The scale has a minimum score of 0 representing no pain and a maximum score of 10 representing the worst possible pain.
次要结局
- Patient Satisfaction(Patient satisfaction will be assessed 6 weeks later at their post-op visit)