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NCT07225101 · ClinicalTrials.gov registry record · Phase 4
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
A Phase 4 study of Traumatic Brain Injury and Brain Tumor Adult, sponsored by University of Michigan.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 160
- Enrollment target
- 1
- Study location
NCT07225101: Recruiting Phase 4 study of Traumatic Brain Injury and Brain Tumor Adult, sponsored by University of Michigan.
NCT07225101 is a Phase 4 study of Traumatic Brain Injury and Brain Tumor Adult that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 160 participants, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (42% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07225101, a Phase 4 study of Traumatic Brain Injury and Brain Tumor Adult, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 160 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The BWAT evaluates 13 categories including size, depth, edges, undermining, necrotic tissue type and amount, exudate type and amount, skin color, peripheral tissue, granulation tissue and epithelialization with a total score of 65. Minimal severity scores are 10-20 out of the total of 65 with good interrater reliability and validation in a variety of clinical environments. Wounds with scores \<10 will be considered healed.
Conditions Studied
Interventions
- DEVICE STRATAFIX PDS and Monocryl suture
Study Locations (1)
Michigan
- University of Michigan Health Sparrow - Lansing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT07225101 shows while recruiting
NCT07225101 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 276-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (42% lower).
The record links to 6 conditions, with Traumatic Brain Injury appearing as the primary indexed condition, and to 1 intervention - of which STRATAFIX PDS and Monocryl suture is the first listed.
NCT07225101 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT07225101 about?
NCT07225101 is a clinical study titled "Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures". 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 peri...
What is the current status of trial NCT07225101?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 2025-11-01. Estimated completion is 2026-12-31.
What conditions does trial NCT07225101 study?
This clinical trial studies the following conditions: Traumatic Brain Injury, Brain Tumor Adult, Spine, Hemorrhagic Stroke, Intracerebral, Wound Closure.
What interventions are being tested in trial NCT07225101?
The interventions under investigation include: STRATAFIX PDS and Monocryl suture (DEVICE).
Who is sponsoring clinical trial NCT07225101?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07225101 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07225101's enrollment target sits among peer trials
160 37th of 171 higher than 131 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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