NCT07225101PHASE4Recruiting
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
University of Michigan
Start Date
11/1/2025
Completion Date
12/31/2026
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
Age Range: 18 years to No maximum
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
Interventions
DEVICE
STRATAFIX PDS and Monocryl suture
Conditions
Wound ClosureBrain Tumor AdultSpineNeurovascularHemorrhagic Stroke, IntracerebralTraumatic Brain Injury
Locations
University of Michigan Health Sparrow
Lansing, Michigan 48912
United States