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Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

RECRUITINGPhase 4Sponsored by University of Michigan
Actively Recruiting
PhasePhase 4
SponsorUniversity of Michigan
Started2025-11-01
Est. completion2026-06-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07225101

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

Age: 18 Years+Healthy volunteers accepted
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

Conditions7

Brain Tumor AdultCancerHemorrhagic Stroke, IntracerebralNeurovascularSpineTraumatic Brain InjuryWound Closure

Locations1 site

University of Michigan Health Sparrow
Lansing, Michigan, 48912
Karen Sagher734-232-4843kfrisch@med.umich.edu

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