Trials / Recruiting
RecruitingNCT07225101
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- University of Michigan · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-11-01
- Primary completion
- 2026-06-30
- Completion
- 2026-12-31
- First posted
- 2025-11-05
- Last updated
- 2025-11-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07225101. Inclusion in this directory is not an endorsement.