Clinical Trial: Delayed Primary Versus Late Secondary Wound Closure in Sternum Infections
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Delayed Primary Versus Late Secondary Wound Closure in the Treatment of Postsurgical Sternum Osteomyelitis
Brief Summary:
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 rand
Detailed Summary:
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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.
Sponsor: University of Lausanne Hospitals
Current Primary Outcome: In hospital Mortality [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- in hospital stay [ Time Frame: 30 days ]
- number of surgical interventions during hospitalization [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: University of Lausanne Hospitals
Dates:
Date Received: July 11, 2011
Date Started: January 2012
Date Completion: July 2014
Last Updated: January 24, 2012
Last Verified: January 2012
