RecruitingPhase 4NCT07225101

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

Sponsor

University of Michigan

Enrollment

160 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Traumatic Brain Injury Brain Tumor Adult Wound Closure Spine Neurovascular Hemorrhagic Stroke, Intracerebral

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

Min Age: 18 Years

Inclusion Criteria1

Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure

Exclusion Criteria2

Patients with prior surgical wound dehiscence or infection
Patients with allergy to suture material

Interventions

DEVICESTRATAFIX PDS and Monocryl suture

STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.