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

NCT07225101 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-11-05

No results posted yet for this study

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
  • Traumatic Brain Injury

Interventions

DEVICE

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.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-06-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07225101 on ClinicalTrials.gov