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STRATAFIX for Neurosurgical Wound Closure Study

This study is looking at how well a device called STRATAFIX works for closing wounds after brain or spine surgery. STRATAFIX is a type of suture (stitches) that is already approved by the FDA. Researchers want to learn more about its safety and how people's bodies react to it over time. You might be able to join if you are an adult having elective or emergency brain or spine surgery that needs stitches for wound closure. The study will measure wound complications using a tool called the Bates-Jensen Wound Assessment Tool (BWAT) score one month after surgery. The current status of this study is unclear, but it plans to enroll about 160 people.

Study design
This is an interventional study planning to enroll 160 participants. It is studying an already FDA-approved device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for wound complications for one month after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07225101

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Michigan
~160 participants
Updated 2025-11-05 on ClinicalTrials.gov
What's tested:STRATAFIX PDS and Monocryl suture

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score
Measured over 1 month

Conditions

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

Explore related trials

Brain NeoplasmClosed woundHemorrhagic StrokeSpineTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Michael Karsy, MD, PhD, MSc · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Karen Sagher
[email protected]
734-232-4843
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score1 month

    The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores \<10 will be considered healed.