Delayed Primary Versus Late Secondary Wound Closure in Sternum Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University of Lausanne Hospitals.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
University Hospital Olomouc
Information provided by (Responsible Party):
Denis Berdajs, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT01473979
First received: July 11, 2011
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Mediastinitis
Procedure: Surgical closure of the poststernotomy wound infection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Delayed Primary Versus Late Secondary Wound Closure in the Treatment of Postsurgical Sternum Osteomyelitis

Resource links provided by NLM:


Further study details as provided by University of Lausanne Hospitals:

Primary Outcome Measures:
  • In hospital Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • in hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • number of surgical interventions during hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A) Secondary closure with the vacuum-assisted system (VAC

after the diagnosis of the poststernotomy wound infection is established the clinical procedure is obtained as follows: firstly the empiric antibiotic therapy with vancomycin is induced. The lab samples including bacteriology test are obtained. Surgical debridement is made until occurrence of tissue bleeding. Finally VAC sponge is implanted wit the negative suction pressure of 75 mmHg.

The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 48/72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Procedure: Surgical closure of the poststernotomy wound infection

Arm A) Secondary closure with the vacuum-assisted system (VAC); The initial surgical revision is done within 24 hours. The first revision with second look and debridement is usually made in 72 hours Subsequently in the following days the wound is stepwise revised during VAC changes.The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Arm B) Surgical procedure by delayed primary closure; The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed. after the sternum is closed by using metallic wires, pectoral muscle on both chest parts is mobilized and closed directly over the bone.

Active Comparator: Arm B) Surgical procedure by delayed primary closure
In the first step, after the diagnosis of the infection was done, and the empiric antibiotic therapy is induced with vancomycin in the first surgical intervention the sternal wires will be removed, the mediastinum is explored and extensive surgical debridement is performed until occurrence of tissue bleeding.The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed.
Procedure: Surgical closure of the poststernotomy wound infection

Arm A) Secondary closure with the vacuum-assisted system (VAC); The initial surgical revision is done within 24 hours. The first revision with second look and debridement is usually made in 72 hours Subsequently in the following days the wound is stepwise revised during VAC changes.The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.

Arm B) Surgical procedure by delayed primary closure; The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed. after the sternum is closed by using metallic wires, pectoral muscle on both chest parts is mobilized and closed directly over the bone.


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 exclusion criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01473979

Contacts
Contact: Denis Berdajs, MD 21 314 2695 ext +41 denis.berdajs@chuv.ch
Contact: Ludwig K von Segesser, Prof 21 314 2695 ludwig.von-segesser@chuv.ch

Locations
Switzerland
Departement of Cardiovascular Surgery, University Hospital Lausanne (CHUV) Not yet recruiting
Lausanne, Switzerland, CH-1011
Contact: Denis Berdajs, MD    21 314 2695    denis.berdajs@chuv.ch   
Sponsors and Collaborators
University of Lausanne Hospitals
University Hospital Olomouc
  More Information

No publications provided

Responsible Party: Denis Berdajs, MD, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT01473979     History of Changes
Other Study ID Numbers: SternumStudy-CHUV-CCV-1
Study First Received: July 11, 2011
Last Updated: January 24, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne Hospitals:
cardiac surgery
poststernotomy wound infections
delayed secondary closure of sternum

Additional relevant MeSH terms:
Mediastinitis
Mediastinal Diseases
Thoracic Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 20, 2014