Stryker Craniomaxillofacial
The purpose of this study is to test an experimental device, the Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant, in spinal surgical procedures. This study is being done to compare Adherus AutoSpray and Adherus AutoSpray ET Dural Sealant to DuraSeal Exact Spinal Sealant, which has already received Federal Food and Drug Administration (FDA) approval in spinal procedures.
This is a prospective, randomized, controlled, single-blind, multicenter, pivotal trial that will evaluate the safety and effectiveness of Adherus Dural Sealant when used in conjunction with standard methods of dural repair in spinal procedures. This trial uses the commercially available DuraSeal Exact as an active control. The trial is designed to demonstrate non-inferiority of Adherus Dural Sealant to DuraSeal Exact. Subjects who are undergoing spinal surgery, consent to participate in this trial and experience a durotomy will be considered for study enrollment. Following a two-tiered inclu…
Inclusion Criteria: 1. Subject is ≥ 18 and ≤ 75 years old. 2. Subject is scheduled for an elective spinal procedure that will require a planned durotomy. 3. Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation is encountered). 4. Subject is able and willing to provide informed consent and HIPAA authorization. 5. Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests. Intra-Operative Inclusion Criteria: 6. Subject has durotomy edges that can…
Adherus Dural Sealant, In situ polymerizing sealant
DuraSeal Exact (P080013b)