STRATAFIX sutures for closing cranial and spine surgical wounds

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.