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Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
RecruitingPhase 4
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
What is being tested
- STRATAFIX PDS and Monocryl suture (device)
Sponsor: University of Michigan · Participants: 160 · Started: Nov 1, 2025
Contact the study team
- Karen Sagher · Phone: 734-232-4843
Official record on ClinicalTrials.gov — NCT07225101
Locations in the U.S.
| Michigan | University of Michigan Health Sparrow, Lansing |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.