RecruitingPhase 4

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

United States160 participantsStarted 2025-11-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score

Timeframe: 1 month

Trial details

NCT IDNCT07225101

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

Contact for this trial

Karen Sagher

734-232-4843 kfrisch@med.umich.edu

View on ClinicalTrials.gov More Wound Closure trials