Phase 3
N=250
Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Elective Cranial Procedures With Dural Incision
Bottom Line
View on ClinicalTrials.gov: NCT01158378 ↗Enrolled (actual)
250
Serious AEs
26.4%
Results posted
Apr 2014
Primary outcome: Primary: Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site — 91.2; 90.6 percentage of subjects — p=0.0049
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adherus Dural Sealant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HyperBranch Medical Technology, Inc
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak / Pseudomeningocele, and Unplanned Retreatment of the Original Surgical Site |
96.6; 91.9 | <0.0001 sig |
| SECONDARY Proportion of Subjects Free of Device-related Surgical Wound Infections or Meningitis During 120-day Follow-up. |
100; 98.3 | — |
Summary
The purpose of the study is to demonstrate the safety and effectiveness of the Adherus Dural Sealant System when used as a dural sealant in conjunction with standard methods of dural repair in cranial procedures.
Eligibility Criteria
Inclusion Criteria
- Pre-Operative Inclusion Criteria
- Subject is scheduled for an elective cranial procedure involving a dural incision using any of the following surgical locations/approaches (or combination): frontal, temporal, occipital, and parietal (i.e. supratentorial), and/or midline or lateral suboccipital (i.e. infratentorial.) Subject requires a procedure involving a Class 1/clean wound (uninfected surgical wound in which no inflammation is encountered)
Intra-Operative Inclusion Criteria
- Subject's linear extent of durotomy is ≥2 cm
- Subject's dural margins from the edges of bony defect are ≥3 mm throughout
- Subject's CSF leak is present intra-operatively following completion of primary dural closure (with or without non-autologous duraplasty or autologous tissue), either spontaneously or upon Valsalva maneuver, at up to 20 cm H2O for up to five (5) seconds
Exclusion Criteria
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells are appropriately sealed (e.g. bone wax).
- Subject has a CSF shunt such as; ventriculo-peritoneal, ventriculo-pleural, ventriculo-atrial or lumbo-peritoneal shunts.
- Subject has an external ventricular or lumbar CSF drain that must be left in place after surgery.
- Subject has had radiation treatment to the surgical site, or standard fractionated radiation therapy is planned within ten days post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure is not an exclusion criterion).
- Subject has a systemic infection or evidence of any infection near planned operative site.
Intra-Operative Exclusion Criteria
- Subject has an Incidental finding that meets any pre-operative exclusion criterion listed above.
- Subject requires the intra-operative placement of a CSF diversion device (e.g. ventricular catheter, subdural catheter, lumbar drain, or other device designed to externally evacuate CSF) that will be left in place after the procedure. Note: Subgaleal drains used for acute post-operative management of the incision site are permitted.
Data sourced from ClinicalTrials.gov (NCT01158378). 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.