Delayed Primary Versus Late Secondary Wound Closure in Sternum Infections
1 other identifier
interventional
100
1 country
1
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 randomized study comparing new delay primary closure of the sternum to the secondary vacuum assisted closure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
November 17, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedJanuary 25, 2012
January 1, 2012
2 years
July 11, 2011
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In hospital Mortality
30 days
Secondary Outcomes (2)
in hospital stay
30 days
number of surgical interventions during hospitalization
30 days
Study Arms (2)
Arm A) Secondary closure with the vacuum-assisted system (VAC
ACTIVE COMPARATORafter 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.
Arm B) Surgical procedure by delayed primary closure
ACTIVE COMPARATORIn 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Lausanne Hospitalslead
- University Hospital Olomouccollaborator
Study Sites (1)
Departement of Cardiovascular Surgery, University Hospital Lausanne (CHUV)
Lausanne, CH-1011, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 11, 2011
First Posted
November 17, 2011
Study Start
January 1, 2012
Primary Completion
January 1, 2014
Study Completion
July 1, 2014
Last Updated
January 25, 2012
Record last verified: 2012-01