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Duragen Versus Duraguard in Chiari Surgery

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ClinicalTrials.gov Identifier: NCT00741858
Recruitment Status : Completed
First Posted : August 26, 2008
Results First Posted : July 13, 2015
Last Update Posted : July 13, 2015
Sponsor:
Information provided by (Responsible Party):
Konstantin V. Slavin, University of Illinois at Chicago

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chiari Malformation
Interventions Procedure: Duragen duraplasty
Procedure: Duraguard duraplasty
Enrollment 34
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DuraGen (Sutureless) DuraGuard (Suturable)
Hide Arm/Group Description

Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.

Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.

Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Period Title: Overall Study
Started 16 18
Completed 16 18
Not Completed 0 0
Arm/Group Title DuraGen (Sutureless) DuraGuard (Suturable) Total
Hide Arm/Group Description

Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.

Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.

Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Total of all reporting groups
Overall Number of Baseline Participants 16 18 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
 100.0%
18
 100.0%
34
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants 18 participants 34 participants
38  (12) 39  (12) 38.7  (12.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 18 participants 34 participants
Female
13
  81.3%
15
  83.3%
28
  82.4%
Male
3
  18.8%
3
  16.7%
6
  17.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants 18 participants 34 participants
16 18 34
1.Primary Outcome
Title Physical Health Quality of Life
Hide Description Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)
Time Frame 7 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DuraGen (Sutureless) DuraGuard (Suturable)
Hide Arm/Group Description:

Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.

Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.

Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

Overall Number of Participants Analyzed 16 18
Mean (Standard Error)
Unit of Measure: units on a scale
31.4  (2.01) 35.61  (1.87)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title DuraGen (Sutureless) DuraGuard (Suturable)
Hide Arm/Group Description

Duragen - the Duragen patch is applied over the dural defect during Chiari decompression surgery. The Duragen represents sutureless technique of posterior fossa duraplasty. Rest of the treatment is as usual.

Duraplasty with Duragen: Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)

Duraguard - the Duraguard patch is applied over the dural defect during Chiari decompression surgery and sutured to the dural edge. This represents suturable technique that theoretically provides better (water-tight) dural closure.

Duraplasty with Duraguard: Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)

All-Cause Mortality
DuraGen (Sutureless) DuraGuard (Suturable)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DuraGen (Sutureless) DuraGuard (Suturable)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/16 (12.50%)      0/18 (0.00%)    
Nervous system disorders     
CSF leak *  2/16 (12.50%)  2 0/18 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DuraGen (Sutureless) DuraGuard (Suturable)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/16 (6.25%)      2/18 (11.11%)    
Nervous system disorders     
meningitis *  1/16 (6.25%)  1 2/18 (11.11%)  2
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: k.v. slavin
Organization: university of illinois at chicago
Phone: 312-996-4842
EMail: kslavin@uic.edu
Layout table for additonal information
Responsible Party: Konstantin V. Slavin, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT00741858     History of Changes
Obsolete Identifiers: NCT00565435
Other Study ID Numbers: UIC 2002-0232
First Submitted: August 25, 2008
First Posted: August 26, 2008
Results First Submitted: June 15, 2015
Results First Posted: July 13, 2015
Last Update Posted: July 13, 2015