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

Part of paid clinical trials in Lansing, Michigan.

Sponsor
University of Michigan
Study ID
NCT07225101
Phase
PHASE4
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STRATAFIX PDS and Monocryl suture — DEVICE
    STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.

Study Details

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.

Key Dates

Start date
Nov 1, 2025
Status verified
Nov 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: STRATAFIX PDS and Monocryl suture
    All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.

Primary Outcome Measure

Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score [ Time Frame: 1 month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Michigan Health SparrowLansingMichigan48912
Karen Sagher
[email protected]
734-232-4843
Michael Karsy, MD, PhD, MSc (PRINCIPAL_INVESTIGATOR)
Nasser M Yaghi, MD (SUB_INVESTIGATOR)

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By research site
University of Michigan Health Sparrow· Lansing, MI

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