STRATAFIX sutures for closing cranial and spine surgical wounds
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
This project will test STRATAFIX sutures for closing cranial and spine surgical wounds in adults to learn about long-term safety and healing.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Lansing, Michigan) |
| Trial ID | NCT07225101 on ClinicalTrials.gov |
What this trial studies
This phase 4 study enrolls adults undergoing elective or emergent cranial or spinal neurosurgery that requires multilayer wound closure and uses STRATAFIX PDS sutures, with Monocryl listed as a comparator. Participants will have their wound outcomes, surgical site infections, dehiscence, and tissue reactions tracked over time to gather long-term safety data. Because STRATAFIX is already FDA-approved, the focus is on real-world performance in neurosurgical applications rather than initial efficacy. Collected information will inform best practices for wound closure in brain and spine procedures.
Who should consider this trial
Good fit: Adults having cranial or spine neurosurgical procedures (elective or emergency) that require multilayer suture closure and who do not have allergy to suture materials are appropriate candidates.
Not a fit: Patients with prior surgical wound dehiscence, active wound infection, or known allergy to the suture materials are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the study could show STRATAFIX provides reliable long-term wound closure with low rates of infection and dehiscence for neurosurgical patients.
How similar studies have performed: STRATAFIX is FDA-approved and has shown good performance for soft-tissue closure in other surgical specialties, but neurosurgery-specific long-term comparative data remain limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lansing, Michigan
- University of Michigan Health Sparrow — Lansing, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Michael Karsy, MD, PhD, MSc — University of Michigan
- Study coordinator: Karen Sagher
- Email: kfrisch@med.umich.edu
- Phone: 734-232-4843
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.