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临床试验/NCT02459093
NCT02459093已完成4 期

Comparison of Subcuticular Suture Type in Post-Cesarean Wound Complications

Montefiore Medical Center4 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2015年5月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
550
试验地点
4
主要终点
Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)

研究概览

简要总结

A comparison of the type of suture used for cesarean skin incision approximation and the subsequent rate of wound complications has not been widely studied. Investigators seek to compare poliglecaprone 25 and polyglactin 910 suture used in a subcuticular skin closure in Pfannenstiel incisions during cesarean birth and determine the subsequent wound complication rates (SSI, hematoma, seroma, wound separation).

详细描述

In the United States cesarean delivery rates in 2012 were 32.8%. The incidence of wound complications post-cesarean delivery has been quoted to be anywhere from 3-30%. Wound complications can include surgical site infection (SSI), hematoma, seroma, and wound separation. Risk factors for wound complications include elevated body mass index (BMI), prolonged duration of surgery, maternal diabetes, coexisting infection (chorioamnionitis), anemia, and increasing number of prior cesarean deliveries. The majority of cesarean deliveries are performed through a suprapubic low-transverse skin incision (Pfannenstiel incision). The incidence of wound complication post-cesarean comparing suture and staple skin closure has been extensively studied with the over all conclusion recommending suture skin closer.

A comparison of the type of suture used for skin closer and wound complication has not been widely studied. Vats et al. compared three types of suture material in post-cesarean wound complication and found statistical difference in wound discomfort, swelling and induration, wound discharge, and wound dehiscence. Their quoted wound complication rate was as high as thirty-three percent. Although, their study population was limited to emergent cesarean deliveries, the sample size was small, and their method of randomization was not explained.

Physiologic wound healing involves five steps: inflammation, granulation, epithelialization, wound contraction, and scar maturation. These biologic processes overlap in occurrence but happen in a defined order. Investigators hypothesize that suture materials with differing profiles will have different effects on these biologic processes. The two most widely used sutures for low-transverse cesarean skin incision closure in our institution are poliglecaprone 25 and polyglactin 910. Poliglecaprone 25 (monocryl) is a monofilament suture with an absorption profile of 91-119 days. Polyglactin 910 (coated vicryl) is a braided suture with an absorption profile of 56-70 days. Given the difference in profile for each suture and the physiologic wound healing process investigators question which would be more effective for wound healing.

The purpose of the study:

  1. To compare poliglecaprone 25 and polyglactin 910 suture in Pfannenstiel incision closure for prevention of wound complication (SSI, hematoma, seroma, wound separation).
  2. To determine if risk factors for wound complication should guide the choice of suture used for closure of Pfannenstiel incision.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age of 37 completed weeks or greater based on their estimated due date calculated from last menstrual period or early ultrasound.
  • Patients participating will be undergoing either:
  • Scheduled cesarean delivery
  • Non-emergent cesarean delivery

排除标准

  • Urogenital tract infection within 2 weeks prior to surgery
  • Chronic oral or injectable steroid use (> 2 weeks)
  • Emergency cesarean delivery (need to deliver immediately due to a maternal or fetal indication)
  • Vertical skin incision
  • Active participation in another research study

研究组 & 干预措施

poliglecaprone 25 suture

Experimental

Subcuticular skin approximation with poliglecaprone 25 suture at cesarean birth surgery

干预措施: poliglecaprone 25 suture (Device)

polyglactin 910 suture

Experimental

Subcuticular skin approximation with polyglactin 910 suture at cesarean birth surgery

干预措施: polyglactin 910 suture (Device)

结局指标

主要结局

Number of Participants With Wound Complications (Surgical Site Infection (SSI), Hematoma, Separation, Seroma, Etc)

时间窗: 30 days

Any wound disruption, fluid accumulation, separation, all CDC defined stages of surgical site infection (SSI)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Garry

Maternal Fetal Medicine Specialist

Montefiore Medical Center

研究点 (4)

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