Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Recruiting
Phase 4
Interventional Study
Wound Closure
Brain Tumor Adult
Spine
Neurovascular
Hemorrhagic Stroke, Intracerebral
Traumatic Brain Injury
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 160 (estimated)
- Sponsor
- University of Michigan · Other
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About This Trial
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…
Trial Locations
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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 …
Contacts