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Fibrin Sealant for the Sealing of Dura Sutures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00681824
First Posted: May 21, 2008
Last Update Posted: June 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Baxter Healthcare Corporation
Results First Submitted: March 12, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Pathological Processes in the Posterior Fossa
Dura Defects
Interventions: Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
Procedure: 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
Participants were enrolled at 12 United States and 1 Canadian clinical site(s) beginning May 2008 and completing in March 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
95 were enrolled. 23 discontinued (10 screen failures, 3 withdrawn by investigator, 3 withdrawn by representative or self, 1 died- failure to thrive, 1 had surgery before randomized, 1 study site distance, 1 site reached enrollment goal, 2 patients cancelled surgery, 1 family delayed >30 day window. 62 randomized. There were 13 run-in participants.

Reporting Groups
  Description
Standard of Care The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
Run-in Participants: FS VH S/D 500 S-apr One initial
FS VH S/D 500 S-apr Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes.

Participant Flow:   Overall Study
    Standard of Care   Run-in Participants: FS VH S/D 500 S-apr   FS VH S/D 500 S-apr
STARTED   28   13   34 
COMPLETED   27   12   33 
NOT COMPLETED   1   1   1 
withdrawn by investigator                0                0                1 
scheduling conflict                1                0                0 
Death                0                1                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.
Primary Safety Dataset Note: This includes 13 initial "run-in" participants in the FS VH S/D 500 s-apr arm (one for each site permitted to familiarize the investigators with the study procedures)

Reporting Groups
  Description
Standard of Care (SoC) The closure of a dura defect by suturing in a patch of autologous fascia, pericranium or suturable collagen-based dura substitute.
FS VH S/D 500 S-apr (Run-In Participants Only) Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group only includes the 13 initial "run-in" participants (one for each site permitted to familiarize the investigators with the study procedures)
FS VH S/D 500 S-apr (Non Run-In Participants Only) Application of thin layer of FS VH S/D 500 s-apr to entire length of suture loop and adjacent area to at least 5 mm away from the suture line, including all suture holes. After application, the product is to be allowed to polymerize for 3 minutes. Note: This arm/group does not include the 13 initial "run-in" participants (one for each site permitted to familiarize the investigators with the study procedures)
Total Total of all reporting groups

Baseline Measures
   Standard of Care (SoC)   FS VH S/D 500 S-apr (Run-In Participants Only)   FS VH S/D 500 S-apr (Non Run-In Participants Only)   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   13   34   75 
Age 
[Units: Years]
Mean (Standard Deviation)
 40.2  (19.7)   42.9  (20.34)   33.3  (19.01)   37.5  (19.6) 
Gender 
[Units: Participants]
       
Female   17   10   21   48 
Male   11   3   13   27 
Region of Enrollment 
[Units: Participants]
       
United States   25   12   30   67 
Canada   3   1   4   8 


  Outcome Measures
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1.  Primary:   Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery   [ Time Frame: 33 +/- 3 days after surgery ]

2.  Primary:   Number of Participants With Cerebrospinal Fluid (CSF) Leakage Observed After Surgery   [ Time Frame: 33 +/- 3 days after surgery ]

3.  Secondary:   Incidence of Procedures Resulting From the Treatment of CSF Leaks   [ Time Frame: until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first ]

4.  Secondary:   Number of Participants With Procedures Resulting From the Treatment of CSF Leaks   [ Time Frame: until resolution or 30 days after final follow-up visit (Day 33+/-3), whichever is first ]

5.  Secondary:   Incidence of Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria   [ Time Frame: within 1 month following surgery ]

6.  Secondary:   Number of Participants With Surgical Site Infections (SSI) According to National Nosocomial Infection Surveillance (NNIS) Criteria   [ Time Frame: within 1 month following surgery ]


  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 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: Guenter Zuelow, Associate Medical Director
Organization: Baxter Healthcare Corporation
e-mail: guenter_zuelow@baxter.com



Responsible Party: Baxter Healthcare Corporation
ClinicalTrials.gov Identifier: NCT00681824     History of Changes
Other Study ID Numbers: 550701
First Submitted: May 19, 2008
First Posted: May 21, 2008
Results First Submitted: March 12, 2013
Results First Posted: June 27, 2013
Last Update Posted: June 27, 2013