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

Plain Language Summary

Simplified for easier understanding

This study is evaluating the safety and performance of a type of surgical suture called STRATAFIX when used to close wounds in brain and spine (neurosurgical) operations. STRATAFIX is a barbed suture designed to hold tissue together without needing knots, potentially reducing closure time and improving wound security. Researchers want to confirm how well it works specifically for layered wound closures in these procedures. **You may be eligible if...** - You are scheduled for a planned (elective) or emergency brain or spine surgery - Your surgery requires sutures for wound closure across multiple tissue layers - The operating surgeon determines this suture type is appropriate for your procedure **You may NOT be eligible if...** - You have had a prior surgical wound that fell apart (wound dehiscence) or became infected at a surgical site - You have a known allergy to the suture material used in STRATAFIX - Your wound closure requirements do not match the use conditions for this suture type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.