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临床试验/NCT01473979
NCT01473979Unknown不适用

Delayed Primary Versus Late Secondary Wound Closure in the Treatment of Postsurgical Sternum Osteomyelitis

University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
In hospital Mortality

研究概览

简要总结

Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1% to 3% with a high mortality rate from 19% to 29% .

The most devastating complication of the open sternum is the laceration of the right ventricle which has a very high mortality. Additionally destabilizations of the thoracic cage, prolonged immobilization, or substantial surgical trauma are further complications of the conventional strategy (4). In addition, postoperative infections after sternotomy are associated with prolonged hospital stay, increased healthcare costs and impaired quality of patient life, representing an economic and social burden. The emergence of increasing antimicrobial resistant bacteria augments the importance of postsurgical infections since the antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an indicator for the quality of patient care in the international benchmark studies.

Although several therapy strategies are nowadays present in clinical practice, there is a lack of evidence based surgical consensus for treatment of this surgical complication. In most case the poststernotomy mediastinitis is involving surgical revision with debridement, open dressing and/or vacuum assisted therapy. After the granulation tissue on open chest wound was achieved secondary closure and/or reconstruction with vascularized soft tissue flaps such as omentum or pectoral muscle is performed.

It seems there is a need for more effective surgical treatment of poststernotomy wound infections, which may address the prolonged hospitalization and reduce number of surgical interventions and with this also perioperative morbidity. In light of this we propose a randomized study comparing new delay primary closure of the sternum to the secondary vacuum assisted closure.

详细描述

  1. Background

1.1. Problem of surgical site infection after sternotomy Sternal osteomyelitis and poststernotomy mediastinitis is a severe and life-treating complication after the cardiac surgery. The incidence of sternal osteomyelitis ranges from 1% to 3% (1, 2) with a high mortality rate from 19% to 29% (1, 3).

The most devastating complication of the open sternum is the laceration of the right ventricle which has a very high mortality. Additionally destabilizations of the thoracic cage, prolonged immobilization, or substantial surgical trauma are further complications of the conventional strategy (4). In addition, postoperative infections after sternotomy are associated with prolonged hospital stay, increased healthcare costs and impaired quality of patient life, representing an economic and social burden. The emergence of increasing antimicrobial resistant bacteria augments the importance of postsurgical infections since the antimicrobial choices are becoming limited. Furthermore, the incidence of infection is an indicator for the quality of patient care in the international benchmark studies.

Although several therapy strategies are nowadays there is a lack of evidence based surgical consensus for treatment of this surgical complication. In most case the poststernotomy mediastinitis is involving surgical revision with debridement, open dressing, vacuum assisted therapy or closed irrigation. After the granulation tissue on open chest wound was achieved secondary closure and/or reconstruction with vascularized soft tissue flaps such as omentum or pectoral muscle is performed. Both open therapy and the flap implantations may be used as a single-line therapy or as a combination of procedures.

1.2. Etiology of poststernotomy infections Many mechanisms have been proposed to explain the development of sternal wound infection. These theories include inadequate sternal fixation leading to instability and dehiscence of the overlying skin incision and inadequate surgical drainage. Further theories suggest a localized ischemic osteomyelitis. This theory suggests that sternal wires become loose, leading to sternal instability, which ultimately leads to skin dehiscence and osteomyelitic infection. The most commonly cultured organism is Staphylococcus Aureus.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or more
  • Who has been operated on the open heart and received a total or partial median sternotomy
  • Informed consent has been obtained, subject is willing to follow protocol study treatment regimen, and comply with all planned follow-up assessments
  • Not self-determined patients are not

排除标准

  • Exclusion Criteria:
  • after heart transplantation or other orthotropic transplantation procedure
  • superficial wound infections (see definition at 4.1)
  • Sterile open wound dehiscence's without any sign of local or systematic infection.

结局指标

主要结局

In hospital Mortality

时间窗: 30 days

次要结局

  • in hospital stay(30 days)
  • number of surgical interventions during hospitalization(30 days)

研究者

发起方
University of Lausanne Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Berdajs

MD

University of Lausanne Hospitals

研究点 (2)

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