Multicenter Infection Surveillance Study Following Open Heart Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halyard Health
ClinicalTrials.gov Identifier:
NCT00673712
First received: May 6, 2008
Last updated: April 16, 2015
Last verified: April 2015
Results First Received: April 3, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Surgery
Pneumonia
Surgical Site Infection
Interventions: Device: Continuous Sternal Block
Drug: Opioid based analgesia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Continuous Sternal Block

Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system

Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic

Opioid Based Analgesia

Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Opioid based analgesia: Opioid Analgesic agents delivered by:

PCA on demand mode IV injections PRN IM injections PRN Oral PRN


Participant Flow:   Overall Study
    Continuous Sternal Block     Opioid Based Analgesia  
STARTED     321     326  
COMPLETED     321     326  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Continuous Sternal Block

Continuous Sternal block with infusion of local anesthetic via ON-Q Painbuster Silver Soaker system

Continuous Sternal Block: Elastomeric Pump for Continuous Infusion of Local Anesthetic

Opioid Based Analgesia

Opioid based analgesia including Patient controlled analgesia plus IM, Oral narcotics and other analgesics

Opioid based analgesia: Opioid Analgesic agents delivered by:

PCA on demand mode IV injections PRN IM injections PRN Oral PRN

Total Total of all reporting groups

Baseline Measures
    Continuous Sternal Block     Opioid Based Analgesia     Total  
Number of Participants  
[units: participants]
  321     326     647  
Age  
[units: years]
Mean (Standard Deviation)
  64.3  (12.1)     65.2  (11.5)     64.7  (11.8)  
Gender  
[units: participants]
     
Female     101     97     198  
Male     220     229     449  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     4     4     8  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     29     26     55  
White     273     277     550  
More than one race     6     12     18  
Unknown or Not Reported     9     7     16  
Region of Enrollment  
[units: participants]
     
United States     321     326     647  



  Outcome Measures
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1.  Primary:   Hospital Acquired Pneumonia   [ Time Frame: 30 days postoperative ]

2.  Secondary:   Surgical Site Infection   [ Time Frame: 30 days postoperative ]

3.  Secondary:   Hospital Length of Stay   [ Time Frame: primary admission ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sr. Director Clinical Research
Organization: Halyard Health
phone: 5132538033
e-mail: alan.dine@hyh.com


No publications provided


Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT00673712     History of Changes
Other Study ID Numbers: iflocv2008
Study First Received: May 6, 2008
Results First Received: April 3, 2015
Last Updated: April 16, 2015
Health Authority: United States: Food and Drug Administration