NCT07225101 Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
| NCT ID | NCT07225101 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Michigan |
| Condition | Wound Closure |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 160 participants in total. It began in 2025-11-01 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Michael Karsy, MD, PhD, MSc
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07225101 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Wound Closure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07225101 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07225101 currently recruiting?
Yes, NCT07225101 is actively recruiting participants. Contact the research team at kfrisch@med.umich.edu for enrollment information.
Where is the NCT07225101 trial being conducted?
This trial is being conducted at Lansing, United States.
Who is sponsoring the NCT07225101 clinical trial?
NCT07225101 is sponsored by University of Michigan. The principal investigator is Michael Karsy, MD, PhD, MSc at University of Michigan. The trial plans to enroll 160 participants.