Cranial Dura Repair
Conditions
Keywords
dura repair following cranial surgery
Brief 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.
Interventions
DEVICESyntheCel
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
DEVICEOther FDA cleared dura replacements
Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele | 6 months | The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale (Patient Function Assessment) | up to 6 months | — |
| Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.) | up to 6 months | — |
| Wound Healing Assessment | up to 6 months | — |
| Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality) | up to 6 months | — |
| Radiographic Evaluation | 6 months | Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit) * Adhesion formation * Membrane formation * Abnormal thickening along graft (device implant) site * Brain edema adjacent to graft (device implant) site |
Countries
United States
Participant flow
Recruitment details
The trial was approved to enroll subjects from a maximum of 10 US medical institutions (public and academic research center hospitals). Subjects were enrolled from February 2006 to June 2008.
Pre-assignment details
A total of 105 patients that initially met the inclusion/exclusion criteria were enrolled and randomized. Of those 105 patients, 99 received surgical treatment. Of those not treated, reasons included: change in diagnosis, not meeting Inclusion/Exclusion criteria, subject voluntary withdrawl, and investigator decision.
Participants by arm
| Arm | Count |
|---|---|
| SyntheCel The investigational group consists of patients who received the SyntheCel Dura Replacement device. | 68 |
| Other FDA Cleared Dura Replacements The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix. | 37 |
| Total | 105 |
Baseline characteristics
| Characteristic | Other FDA Cleared Dura Replacements | SyntheCel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 13 Participants |
| Age, Categorical Between 18 and 65 years | 31 Participants | 61 Participants | 92 Participants |
| Age Continuous | 48.6 years STANDARD_DEVIATION 14.03 | 46.5 years STANDARD_DEVIATION 12.85 | 47.2 years STANDARD_DEVIATION 13.25 |
| Region of Enrollment United States | 37 participants | 68 participants | 105 participants |
| Sex: Female, Male Female | 25 Participants | 50 Participants | 75 Participants |
| Sex: Female, Male Male | 12 Participants | 18 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 57 / 62 | 30 / 37 |
| serious Total, serious adverse events | 23 / 62 | 9 / 37 |
Outcome results
Primary
Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele
The primary endpoint for measuring effectiveness is such that an individual patient's treatment success requires the absence of CSF fistula (drainage from wound or sinus) and pseudomeningocele within 6 months post-operatively confirmed by radiographic evaluation and physical examination of the surgical site.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SyntheCel | Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele | 57 participants |
| Other FDA Cleared Dura Replacements | Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele | 33 participants |
Secondary
Assessment of Changes in Body Systems (e.g., Head, Neurovascular, Etc.)
Time frame: up to 6 months
Secondary
Device Handling Characteristics (i.e., Ease of Use, Strength, Suturability, Seal Quality)
Time frame: up to 6 months
Secondary
Modified Rankin Scale (Patient Function Assessment)
Time frame: up to 6 months
Secondary
Radiographic Evaluation
Radiographic evaluation (to determine the presence or absence of the following at the 6 month follow-up visit) * Adhesion formation * Membrane formation * Abnormal thickening along graft (device implant) site * Brain edema adjacent to graft (device implant) site
Time frame: 6 months
Secondary
Wound Healing Assessment
Time frame: up to 6 months