Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure
Locations
United States
Michigan
University of Michigan Health Sparrow
RECRUITING
Lansing
Contact Information
Primary
Karen Sagher
kfrisch@med.umich.edu
734-232-4843
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 160
Treatments
Experimental: STRATAFIX PDS and Monocryl suture
All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.
Related Therapeutic Areas
Sponsors
Leads: University of Michigan
Collaborators: Johnson & Johnson