Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures (NCT07225101) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing STRATAFIX sutures specifically in neurosurgical procedures like brain tumor removal, spine surgery, and stroke treatment, can you tell me whether this type of wound closure technique is already considered standard care for my particular procedure, and how it differs from what you'd normally use?
2The trial is measuring wound complications using a tool called the Bates-Jensen Wound Assessment Tool — does that mean there's still uncertainty about how well these sutures perform in neurosurgical settings, and what wound complications are they specifically watching for?
3Since this is a Phase 4 trial, meaning the sutures are already FDA-approved but being studied further in neurosurgical contexts, does that change how you weigh the risks compared to a trial testing something entirely new?
4My condition falls into one of several categories this trial covers — brain tumor, spine, stroke, or traumatic brain injury — and I'm wondering whether the wound closure technique being studied would be the same across all those different surgeries, or does it depend on which procedure I need?
5If I don't participate in this trial, would you use a different suturing method for my surgery, and is there any reason to think one approach might be better for my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.