跳至主要内容
临床试验/NCT02028000
NCT02028000终止不适用

Post-Operative Pain and Skin Closure Methods After Cesarean Section

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年1月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
10
试验地点
2
主要终点
6 week postoperative subjective pain score

研究概览

简要总结

The study is looking at women undergoing cesarean section delivery of their baby. The purpose of this research study is to determine what type of skin closure after cesarean section helps decrease pain level the most and improves the appearance of the incision site.

The study hypothesis is to determine if skin closure with absorbable subcuticular staples leads to improved cosmesis and/or decreased post-operative pain.

Participants in the study will already be scheduled for a cesarean section for delivery of their baby. They will be randomized into one of three groups, 1) Insorb (absorbable subcuticular stapes), 2) Vicryl suture or 3) Monocryl suture for the skin closure of their cesarean section. Information that will be recorded includes amount of pain medication usage while in the hospital after cesarean section, daily patient rated pain score until discharge from hospital, pain score 6 weeks after surgery and cesarean section cosmetic scar 6 weeks after surgery.

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 Centers for Disease Control National Vital Statistics Report 32.3% of all births in the United States were via cesarean delivery, marking the twelfth consecutive annual increase in the cesarean delivery rate. 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.

The topic of skin closure after cesarean delivery is an area that has been the focus of several randomized control trials. The trials compared surgical steel staples to subcuticular suture of various materials focusing on differences in post-operative pain, infection rates, and scar cosmesis. Cosmesis has been investigated in all three Randomized Clinical Trials and none have found differences between surgical steel staples and subcuticular suture. Infection rate has been studied in a single observational study which found a higher infection rate in those patients whose skin was closed with surgical steel staples compared to suture. Studies of post-operative pain and skin closure technique have been contradictory. The earliest Randomized clinical trial to investigate skin closure and post-operative pain was done by Frishman et al (5) and found that subjective self-assessment of pain was better at hospital discharge and 6 weeks post-operatively in patients when subcuticular suture rather than surgical steel staples were used. A subsequent Randomized clinical trial reported the opposite result with less pain 6 weeks post-operatively when surgical steel staples were used. This discrepancy may, in part, be due to the different suture material used in the two trials. The study by Frishman et al which showed a benefit of subcuticular suture utilized used polyglycolic acid (Vicryl suture or Insorb staples); whereas, the study by Rousseau et al used polyglecaprone (Monocryl suture). To date direct comparison of skin closure at the time of cesarean with these two suture materials has not been performed.

Recently, a new technology for skin closure has been introduced that employs absorbable material, polylactic and polyglycolic acid, in subcuticular staples. In animal models this method of skin closure has shown less histological inflammation and fewer wound infections than either surgical steel staples or subcuticular suture. Unfortunately, little is known about how this skin closure technique compares to the other more established techniques after cesarean delivery in humans. However, a retrospective analysis comparing subcuticular absorbable staples with surgical steel staples revealed an association between subcuticular absorbable staples and decreased in-hospital analgesic use. The current study is a prospective randomized trial that investigates four cesarean skin closure techniques-surgical steel staples, subcuticular polyglycolic acid suture (Vicryl), subcuticular, polyglecaprone suture (Monocryl), and absorbable subcuticular polyglycolic acid staples-to determine if one is associated with improved cosmesis or a decrease in post-operative pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18-44
  • Any parity
  • Scheduled Cesarean Section
  • Neuraxial analgesia

排除标准

  • Diabetes Mellitus
  • Maternal Connective Tissue Disorder
  • Maternal Steroid Use

研究组 & 干预措施

INSORB staples skin closure

Active Comparator

Women undergoing cesarean section delivery will have skin closure with INSORB staples.

干预措施: Monocryl skin closure (Procedure)

INSORB staples skin closure

Active Comparator

Women undergoing cesarean section delivery will have skin closure with INSORB staples.

干预措施: Vicryl skin closure (Procedure)

Monocryl skin closure

Active Comparator

Women undergoing cesarean section delivery will have skin closure with Monocryl.

干预措施: Insorb staples skin closure (Procedure)

Monocryl skin closure

Active Comparator

Women undergoing cesarean section delivery will have skin closure with Monocryl.

干预措施: Vicryl skin closure (Procedure)

Vicryl skin closure

Active Comparator

Women undergoing cesarean section delivery will have Vicryl skin closure

干预措施: Insorb staples skin closure (Procedure)

Vicryl skin closure

Active Comparator

Women undergoing cesarean section delivery will have Vicryl skin closure

干预措施: Monocryl skin closure (Procedure)

结局指标

主要结局

6 week postoperative subjective pain score

时间窗: After cesarean section delivery at the 6 week postpartum visit

Patient rated subjective pain score 6 weeks postoperatively will be recorded.

Intravenous and analgesic use.

时间窗: Admission for delivery of baby by cesarean section to expected postpartum average of 6 weeks

Record the amount of in hospital intravenous and oral analgesic use.

Daily subjective pain score while hospitalized

时间窗: Hospital admission for cesarean section delivery

Daily patient rated subjective pain score (0-10 based on visual analog scale) until dismissal from the hospital will be recorded.

Scar cosmetic score 6 weeks post-operatively.

时间窗: 6 weeks post-operatively after cesarean section

6 weeks post-operative scar cosmetic score will be recorded.

次要结局

  • Length of hospital stay(C/S admission to discharge time)
  • Wound complications(Time of cesarean section until 6 weeks postpartum visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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