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临床试验/NCT00932503
NCT00932503已完成不适用

Do Triclosan Coated Sutures Reduce Wound Infections After Hepatobiliary Surgery? A Prospective Non Randomized Clinical Pathway Driven Study.

University Hospital, Saarland2 个研究点 分布在 1 个国家目标入组 839 人开始时间: 2003年10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
839
试验地点
2
主要终点
The primary outcome was the number of wound infections.

研究概览

简要总结

The aim of this study was to ascertain if the use of Vicryl plus® reduced the number of wound infections after transverse laparotomy comparing to polydioxanon suture.

详细描述

All patients are treated using clinical pathways (CP) to standardise surgical procedures in our high volume centre. Part of the clinical process management was the standardisation of wound incision and abdominal wall closure.

Wound closure is achieved by a two-layer technique using continuous absorbable loop suture. The suture length to incision length ratio is at least 4:1. The running sutures are 1 cm apart and at least 1.5 cm from the wound edge 14. In the first timeperiod (TP1), the CP step for fascia closure foresees a PDS loop suture (PDS II®, 150 cm, Ethicon GmbH, Norderstedt, Germany). After the recruitment of 400 patients, that CP step is altered to the use of a triclosan-coated polyglactin 910 loop suture (Vicryl plus®, 150 cm, Ethicon GmbH, Norderstedt, Germany). The primary outcome is the number of wound infections. Patients demographic and disease as well as procedure related data are collected in a clinical information system (ISHmed on SAP platform, GSD, Berlin, Germany) prospectively. Risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the American Society of Anesthesiologists (ASA), are collected prospectively to compare the two groups.

研究设计

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

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

  • surgical pathologies accessed via transverse abdominal incision
  • primary fascial closure

排除标准

  • pregnancy
  • age under 18 years
  • open abdominal treatment
  • known hypersensitivity agains PDS/Vicryl/Triclosan

结局指标

主要结局

The primary outcome was the number of wound infections.

时间窗: 10 days after demission of patient from hospital

次要结局

  • The secondary outcome was the number of incisional hernia(follow up points: 6 month, 1 year, 2 years and 3 years)

研究者

发起方
University Hospital, Saarland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christoph Justinger

Christoph Justinger, MDDepartment of General, Visceral, Vascular, and Pediatric Surgery

University Hospital, Saarland

研究点 (2)

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