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临床试验/NCT00508053
NCT00508053已完成不适用

When Closing Midline Incisions, do Small Stitches Reduce the Risk for Incisional Hernia, Wound Infection or Dehiscence?

Sundsvall Hospital1 个研究点 分布在 1 个国家目标入组 737 人开始时间: 2001年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
737
试验地点
1
主要终点
Frequency of wound infection

研究概览

简要总结

The purpose of this study is to determine whether a technique using very small stitches when closing a midline incision can reduce the risk for wound complications such as incisional hernia, infection or dehiscence.

详细描述

Most abdominal surgical operations are made through a midline incision and 10% of the patients may get a wound infection. Infection is a risk factor for incisional hernia, which 12 months after the operation can be seen in 10-20% of the patients. Wound dehiscence is seen in approximately 1% of the patients. Surgery because of incisional hernias are common and in Sweden approximately 2000 patients per year needs an operation creating big costs. We know that a midline incision should be closed using a continuous technique, with a suture length to wound length ratio over 4. An earlier interventional study at the Surgical Department in Sundsvall showed that using that technique reduced the risk for hernia with 50%. Subsequent experimental studies indicates that the suture length to wound length ratio should be obtained by small stitches, placed close to each other only incorporating the aponeurosis, and not by large stitches incorporating the complete abdominal wall (mass closure). The hypothesis that midline incisions should be closed with small stitches only incorporating the aponeurosis has to be tested in a clinical trial.

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
Double

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female patient with an acute or planned operation trough a midline incision at the Surgical Department in Sundsvall, Sweden

排除标准

  • Age under 18
  • Previous surgery through a midline incision
  • Scars from previous surgery crossing the midline
  • Preexisting hernia in the midline (umbilical, epigastric)

结局指标

主要结局

Frequency of wound infection

时间窗: Within the first 30 days after surgery

Frequency of incisional hernia

时间窗: One year after surgery

次要结局

  • Frequency of wound dehiscence(Within the first 10 days after surgery)
  • Effect of different suture techniques on wound complications related to patient characteristics such as age, BMI, sex etc. and operative characteristics such as emergency surgery, type of surgery, degree of contamination, surgeon,etc..(Within 1 year.)

研究者

发起方
Sundsvall Hospital
申办方类型
Other

研究点 (1)

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