Duragen Versus Duraguard in Chiari Surgery
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | April 2003 |
| End Date: | April 2010 |
Prospective Randomized Study of Duragen vs. Duraguard in Chiari Surgery
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.
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.
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.
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.
Inclusion Criteria:
- Symptomatic Chiari malformation
Exclusion Criteria:
- Presence of ventriculoperitoneal shunt
- Pregnancy
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