Chiari Malformation
Conditions
Keywords
Chiari malformation;, Duraplasty;, Posterior fossa decompression;, Duragen;, Duraguard
Brief summary
The study evaluates two materials used for duraplasty of the posterior cranial fossa in treatment of Chiari malformation. One material (DuraGen) is a non-suturable collagen matrix that is applied over the defect if brain coverings (dura); the other (DuraGuard) is made out of bovine pericardium and has to be sutured during application. The study compares these two materials used for duraplasty of patients undergoing Chiari surgery in a prospective randomized fashion to check the rate of surgical complications associated with each material, patient's outcomes, length of surgery and the hospital stay, etc.
Detailed description
The study is aimed at comparative analysis of two frequently used duraplasty materials: one is made out of bovine pericardium, and the other - from bovine collagen derived from bovine achilles tendon. Both materials are routinely used form this intervention (duraplasty), but the question of superiority of one over the other remains open. This study follows patients with Chiari malformation from the time of surgery to the time of their discharge from the hospital and then another 3 months of follow up care.
Interventions
PROCEDUREDuragen duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duragen)
PROCEDUREDuraguard duraplasty
Posterior cranial fossa repair and enlargement with application of dural patch (Duraguard)
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Symptomatic Chiari malformation
Exclusion criteria
* Presence of ventriculoperitoneal shunt * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Health Quality of Life | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 16 |
| 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) | 18 |
| Total | 34 |
Baseline characteristics
| Characteristic | DuraGuard (Suturable) | DuraGen (Sutureless) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 16 Participants | 34 Participants |
| Age, Continuous | 39 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 12 | 38.7 years STANDARD_DEVIATION 12.2 |
| Region of Enrollment United States | 18 participants | 16 participants | 34 participants |
| Sex: Female, Male Female | 15 Participants | 13 Participants | 28 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 16 | 2 / 18 |
| serious Total, serious adverse events | 2 / 16 | 0 / 18 |
Outcome results
Primary
Physical Health Quality of Life
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| DuraGen (Sutureless) | Physical Health Quality of Life | 31.4 units on a scale | Standard Error 2.01 |
| DuraGuard (Suturable) | Physical Health Quality of Life | 35.61 units on a scale | Standard Error 1.87 |