Study to Evaluate Safety & Effectiveness of Spinal Sealant

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by (Responsible Party):
Integra LifeSciences Corporation
ClinicalTrials.gov Identifier:
NCT00444067
First received: March 6, 2007
Last updated: September 4, 2014
Last verified: September 2014
Results First Received: July 17, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Cerebrospinal Fluid Leakage, Subdural
Interventions: Device: Spinal Sealant
Other: Standard of Care

  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
The first subject was consented on May 15, 2007. The last subject visit occurred on August 12, 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Washout study, no run-in or wash-out periods.

Reporting Groups
  Description
Spinal Sealant DuraSeal Spinal Sealant System
Control Standard of care methods used as an adjunct to sutured dural repair.

Participant Flow:   Overall Study
    Spinal Sealant     Control  
STARTED     74     24  
COMPLETED     74     23  
NOT COMPLETED     0     1  
Lost to Follow-up                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Spinal Sealant DuraSeal Spinal Sealant System
Control Standard of care methods used as an adjunct to sutured dural repair.
Total Total of all reporting groups

Baseline Measures
    Spinal Sealant     Control     Total  
Number of Participants  
[units: participants]
  74     24     98  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     69     23     92  
>=65 years     5     1     6  
Gender  
[units: participants]
     
Female     30     9     39  
Male     44     15     59  
Region of Enrollment  
[units: participants]
     
United States     74     24     98  
Age (Statistics)  
[units: years]
Mean ± Standard Deviation
  44.25  ± 13.06     44.70  ± 11.44     44.36  ± 12.62  



  Outcome Measures
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1.  Primary:   Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)   [ Time Frame: Intra-operative ]

2.  Other Pre-specified:   Incidence of Post-Operative CSF Leaks   [ Time Frame: 90 Days ]

3.  Other Pre-specified:   Incidence of Post-Operative Surgical Site Infections (SSIs)   [ Time Frame: 90 Days ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Jen Doyle
Organization: Confluent Surgical Inc., dba Covidien
phone: 781.839.1770
e-mail: Jennifer.doyle@covidien.com


No publications provided


Responsible Party: Integra LifeSciences Corporation
ClinicalTrials.gov Identifier: NCT00444067     History of Changes
Other Study ID Numbers: DS3-06-002
Study First Received: March 6, 2007
Results First Received: July 17, 2012
Last Updated: September 4, 2014
Health Authority: United States: Food and Drug Administration