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Recruiting Phase 4 NCT07225101
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Trial Parameters
Condition Wound Closure
Sponsor University of Michigan
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 160
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-01
Completion 2026-06-30
All Conditions
Interventions
STRATAFIX PDS and Monocryl suture
Brief Summary
This research is studying a device already approved by the Food and Drug Administration (FDA) to treat wound closures. Researchers are studying a large group of people to continue to learn information about the safety of the STRATAFIX suture and how people's bodies react to using it over a long period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.
Eligibility Criteria
Inclusion Criteria: * Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure Exclusion Criteria: * Patients with prior surgical wound dehiscence or infection * Patients with allergy to suture material