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临床试验/NCT01938222
NCT01938222已完成不适用

A Prospective, Controlled Monocentric Study Evaluating the 6:1 Suture Technique Using Suture Material Monomax® for Abdominal Wall Closure After Primary Abdominal Incision

Diakonie-Klinikum Schwäbisch Hall gGmbH1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
351
试验地点
1
主要终点
Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification

研究概览

简要总结

A number of studies identifies abdominal hernia as the most frequent postoperative complication following laparotomy with percentages of 9-20% - depending on duration of follow-up. It is based on a multifactorial basis, including factors concerning individual, patient-specific factors, factors related to the operational technique as well as particular surgical factors. Wound complications have been reported by 7-12%, burst abdomen rate (dehiscence) < 5 days being 2-4%, wound infection rate (+/- wound dehiscence) ≥ 5 days being 6-10%. In emergency procedures (e.g. ileus, perforation of hollow organ) a wound complication rate of up to 50 % has to be expected. According to new, first findings from recent studies the rates of wound healing complication and burst abdomen can be reduced significantly. Depending on the study, to almost 50%. The principle is based on the reduction of the stitch length and type of the inserted suture. The stitches are closer and with less distance to the edge of fascia. Due to the much thinner suture it still comes here to a quantitative reduction of the inserted suture. The data collected using the MonoMax® suture in the short stitch technique will be compared to the results of the ISSAAC trial, in which the MonoMax® suture was used in the long stitch suture technique. The generated data are thus subject of retrospective comparison with a historical control group (ISSAAC study).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Age 18 years and older
  • Primary elective and primary emergency laparotomy
  • Written informed consent

排除标准

  • Pregnant women

结局指标

主要结局

Wound-infection rate until day of discharge according to CDC (Centre of Disease Control) Classification

时间窗: until discharge (ca. 10 days after operation)

次要结局

  • Use of the suture material (tissue drag, elasticity, knot security, knot pull tensile strength, knot run-down)(intraoperative)
  • Reoperation rate due to burst abdomen until discharge(until discharge (ca. 10 days after operation))
  • Wound healing complications until discharge(until discharge (ca. 10 days after operation))
  • Length of postoperative hospital stay(until discharge (ca. 10 days after operation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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