Trial Outcomes & Findings for Duragen Versus Duraguard in Chiari Surgery (NCT NCT00741858)

NCT ID: NCT00741858

Last Updated: 2015-07-13

Results Overview

Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 34 participants
• Primary outcome timeframe: 7 years
• Results posted on: 2015-07-13

Participant Flow

Participant milestones

Measure	DuraGen (Sutureless) 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 (Suturable) 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 Study STARTED	16	18
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duragen Versus Duraguard in Chiari Surgery

Baseline characteristics by cohort

Measure	DuraGen (Sutureless) n=16 Participants 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 (Suturable) n=18 Participants 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 n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	18 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38 years STANDARD_DEVIATION 12 • n=5 Participants	39 years STANDARD_DEVIATION 12 • n=7 Participants	38.7 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	15 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	18 participants n=7 Participants	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 years

Physical health quality of life (based on SF-36 results) (SF-36 includes 8 scores scaled 0-100; lower score indicating more disability)

Outcome measures

Measure	DuraGen (Sutureless) n=16 Participants 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 (Suturable) n=18 Participants 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)
Physical Health Quality of Life	31.4 units on a scale Standard Error 2.01	35.61 units on a scale Standard Error 1.87

Adverse Events

DuraGen (Sutureless)

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

DuraGuard (Suturable)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	DuraGen (Sutureless) n=16 participants at risk 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 (Suturable) n=18 participants at risk 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)
Nervous system disorders CSF leak	12.5% 2/16 • Number of events 2 • 3 months	0.00% 0/18 • 3 months

Other adverse events

Measure	DuraGen (Sutureless) n=16 participants at risk 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 (Suturable) n=18 participants at risk 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)
Nervous system disorders meningitis	6.2% 1/16 • Number of events 1 • 3 months	11.1% 2/18 • Number of events 2 • 3 months

Additional Information

k.v. slavin

university of illinois at chicago

Phone: 312-996-4842

Email: kslavin@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place