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Multicenter Infection Surveillance Study Following Open Heart Surgery

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ClinicalTrials.gov Identifier: NCT00673712
Recruitment Status : Completed
First Posted : May 7, 2008
Results First Posted : May 4, 2015
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Halyard Health

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Surgery
Pneumonia
Surgical Site Infection
Interventions: Device: Continuous Sternal Block
Drug: Opioid based analgesia

  Participant Flow

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

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.
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

Total Total of all reporting groups

Baseline Measures
   Continuous Sternal Block   Opioid Based Analgesia   Total 
Overall Participants Analyzed 
[Units: Participants]
 321   326   647 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.3  (12.1)   65.2  (11.5)   64.7  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      101  31.5%      97  29.8%      198  30.6% 
Male      220  68.5%      229  70.2%      449  69.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      4   1.2%      4   1.2%      8   1.2% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      29   9.0%      26   8.0%      55   8.5% 
White      273  85.0%      277  85.0%      550  85.0% 
More than one race      6   1.9%      12   3.7%      18   2.8% 
Unknown or Not Reported      9   2.8%      7   2.1%      16   2.5% 
Region of Enrollment 
[Units: Participants]
     
United States   321   326   647 


  Outcome Measures

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

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
No text entered.


  More Information

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



Responsible Party: Halyard Health
ClinicalTrials.gov Identifier: NCT00673712     History of Changes
Other Study ID Numbers: iflocv2008
First Submitted: May 6, 2008
First Posted: May 7, 2008
Results First Submitted: April 3, 2015
Results First Posted: May 4, 2015
Last Update Posted: January 19, 2018