Phase 3
Completed N=34
Duragen Versus Duraguard in Chiari Surgery
Chiari Malformation
Source: ClinicalTrials.gov NCT00741858 ↗
Enrolled (actual)
34
Serious AEs
5.9%
Results posted
Jul 2015
Primary outcomePrimary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Physical Health Quality of Life |
31.4; 35.61 | — |
Eligibility Criteria
Inclusion Criteria
- Symptomatic Chiari malformation
Exclusion Criteria
- Presence of ventriculoperitoneal shunt
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00741858). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.