Study of SyntheCelTM Dura Replacement to Other Dura Replacements

DePuy Synthes

Status

Completed

Conditions

Cranial Dura Repair

Treatments

Device: Other FDA cleared dura replacements

Device: SyntheCel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00859508

SyntheCel

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is between 18 and 75 years of age
Patient is scheduled for an elective cranial procedure requiring a dural incision
Patient has an MRI no earlier than two months prior to the date of enrollment
Surgical wound is expected to be Class I/clean
Patient is available and willing to participate in the investigation for the duration of the study
Patient has signed a written Informed Consent to participate in the study prior to any study mandated determinations or procedures. This does not include MRIs that may be performed prior to obtaining informed consent.

Exclusion criteria

Patient has a cranial metallic implant(s) that would interfere with evaluation of the device or recovery
Patient is somnolent or comatose (Glasgow score< 8)
Patient has had a prior intracranial neurosurgical procedure in the same anatomical location
Patient will require use of a dural adhesive or sealant
Patient has known hydrocephalus
Patient's life expectancy is less than 6 months
Patient has a systemic infection (e.g. urinary tract infection (UTI), active pneumonia) or evidence of any surgical site infection, fever > 101°F, positive blood culture and/or a positive chest x-ray for acute infectious process
Patient has known allergy to device component (cellulose)
Patient is an acute cranial trauma surgical case
Patient has a local cranial infection
Patient has had chemotherapy and/or radiation treatment within 12 weeks prior to surgery, or has chemotherapy and/or radiation treatment planned 10 weeks post surgery
Patient has been clinically diagnosed with malignancy (other than basal cell carcinoma or low grade glioma), uncontrolled diabetes, sepsis, systemic collagen disease
Patient has creatinine levels > 2.0 mg/dL
Patient has total bilirubin level > 2.5 mg/dL
Patent has clinically significant coagulopathy with a partial thromboplastin time (PTT) ≥ 35, international normalized ratio (INR) ≥ 1.2, or is receiving Warfarin or Coumadin
Patient has a compromised immune system or autoimmune disease (white blood cell (WBC) count <4000/uL or >20,000/uL)
Patient is participating in another clinical trial using investigational devices/drugs
Patient is pregnant or breastfeeding or wishes to become pregnant during the course of the study
Patient is unable or unwilling to sign a consent form