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Study of SyntheCelTM Dura Replacement to Other Dura Replacements

2014-07-24 14:14:04 | BioPortfolio

Summary

Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Cranial Dura Repair

Intervention

SyntheCel, Control

Status

Completed

Source

Synthes Spine

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:14:04-0400

Clinical Trials [838 Associated Clinical Trials listed on BioPortfolio]

SyntheCel Dura Replacement in Patients Requiring Dura Repair

The objective of the clinical investigation is to demonstrate that the SyntheCelTM Dura Replacement is substantially equivalent to other dura replacements cleared for marketing by the FDA ...

Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients unde...

Effect of Dural Release on Women With Back and Neck Pain After Obstetrics and Gynecological Surgery

Something must be done in order to release the tension within the dura mater before any lasting correction of the spine can be effected. Each of the cranial nerves is wrapped in a sheath o...

A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.

The objective of this study is to evaluate the safety and effectiveness of ArtiFascia® in comparison with commercially available dural substitutes in patients requiring Dural repair follo...

Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing ele...

PubMed Articles [10181 Associated PubMed Articles listed on BioPortfolio]

Repair of Cranial Bone Defects in Children Using Synthetic Hydroxyapatite Cranioplasty (Custombone).

In pediatric cases, the use of autologous bone tissue to repair cranial bone defects is often impossible. The synthetic hydroxyapatite bone substitute (CUSTOMBONE) can be a good alternative especially...

Case Report of a Novel Technique for Repair of the Vertebral Artery During Cranial Surgery.

Surgery of complex cranial base lesions carries a high risk of damage to main vessels, often resulting in life-changing or even life-threatening injuries. We describe a rapid, effective, and noninvasi...

Mechanical and morphological description of human acellular dura mater as a scaffold for surgical reconstruction.

As native human dura mater has been successfully used as a transplant, the acellular dura mater scaffold is a promising material for the same purpose, that is less prone to transplant rejection. A det...

Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Performance of Dura Sealant Patch in Reducing Cerebrospinal Fluid Leakage Following Elective Cranial Surgery: The ENCASE Trial Study Protocol.

Cerebrospinal fluid (CSF) leakage is one of the most common neurosurgical complications, occurring in 4% to 32% of surgical cases, with a higher incidence in complicated skull base surgery, intradural...

Primary, dural-based, Ewing sarcoma manifesting with seizure activity: Presentation of a rare tumor entity with literature review.

Primary Ewing sarcoma arising from the calvarial bone and/or underlying dura matter are relatively rarely reported in the literature. Even rarer are considered to be those that originate from the dura...

Medical and Biotech [MESH] Definitions

Large endothelium-lined venous channels situated between the two layers of DURA MATER, the endosteal and the meningeal layers. They are devoid of valves and are parts of the venous system of dura mater. Major cranial sinuses include a postero-superior group (such as superior sagittal, inferior sagittal, straight, transverse, and occipital) and an antero-inferior group (such as cavernous, petrosal, and basilar plexus).

Accumulation of blood in the EPIDURAL SPACE between the SKULL and the DURA MATER, often as a result of bleeding from the MENINGEAL ARTERIES associated with a temporal or parietal bone fracture. Epidural hematoma tends to expand rapidly, compressing the dura and underlying brain. Clinical features may include HEADACHE; VOMITING; HEMIPARESIS; and impaired mental function.

A skull fracture characterized by inward depression of a fragment or section of cranial bone, often compressing the underlying dura mater and brain. Depressed cranial fractures which feature open skin wounds that communicate with skull fragments are referred to as compound depressed skull fractures.

The reconstruction of a continuous two-stranded DNA molecule without mismatch from a molecule which contained damaged regions. The major repair mechanisms are excision repair, in which defective regions in one strand are excised and resynthesized using the complementary base pairing information in the intact strand; photoreactivation repair, in which the lethal and mutagenic effects of ultraviolet light are eliminated; and post-replication repair, in which the primary lesions are not repaired, but the gaps in one daughter duplex are filled in by incorporation of portions of the other (undamaged) daughter duplex. Excision repair and post-replication repair are sometimes referred to as "dark repair" because they do not require light.

A branch of the trigeminal (5th cranial) nerve. The mandibular nerve carries motor fibers to the muscles of mastication and sensory fibers to the teeth and gingivae, the face in the region of the mandible, and parts of the dura.

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