Recruiting

STRATAFIX

Sponsor:

University of Michigan

Code:

NCT07225101

Conditions

Wound Closure

Brain Tumor Adult

Spine

Neurovascular

Hemorrhagic Stroke, Intracerebral

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

STRATAFIX PDS and Monocryl suture

Study Details

Brief 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.

Conditions

Wound Closure

Brain Tumor Adult

Spine

Neurovascular

Hemorrhagic Stroke, Intracerebral

Study ID

NCT07225101

Start date

Nov 1, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: STRATAFIX PDS and Monocryl suture

All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.

Interventions

STRATAFIX 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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Karen Sagher

734-232-4843kfrisch@med.umich.edu

Locations

University of Michigan Health Sparrow

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Karen Sagher

734-232-4843kfrisch@med.umich.edu

Principal Investigator:

Michael Karsy, MD, PhD, MSc

More Information

Sponsor

University of Michigan

Last update posted

Nov 5, 2025

Last verified

Nov, 2025

Keywords

  • Superficial surgical site infection
  • Suture material
  • Wound closure techniques
  • brain tumor
  • spine
  • spine trauma
  • neurosurgery
  • hemorrhagic stroke
  • traumatic brain injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-11-05.