Actively Recruiting
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Led by University of Michigan · Updated on 2025-11-05
160
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Michigan
Lead Sponsor
J
Johnson & Johnson
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and long-term effects of the STRATAFIX suture device, which is already approved by the FDA for wound closures. This study focuses on people undergoing neurosurgical procedures on the brain or spine and aims to gather more information on how the body reacts to the STRATAFIX suture over time and its safety in closing surgical wounds. All participants will have their planned neurosurgical cranial or spine surgery with their wounds closed using the STRATAFIX PDS and Monocryl suture. This device uses barbed components to hold wound tension and is designed to be a long-lasting absorbable suture. The study does not include a comparison group, and all enrolled participants will receive the STRATAFIX suture treatment during their surgery. Participants will be monitored for wound healing and complications at 1, 3, and 6 months after surgery using tools such as the Bates-Jensen Wound Assessment Tool and Wound-Quality of Life questionnaires. Researchers will also track surgical site infections, patient satisfaction, wound imaging, and any need for wound revision. The time taken to close wounds and adherence to the suturing method will be recorded immediately after surgery. The study may last up to six months post-surgery for each participant.
CONDITIONS
Brief Title
Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Elective or emergent surgical approaches for cranial or spine neurosurgical procedures requiring sutures for wound closure
- Requirement for multilayer wound closure
- Age 18 years or older
You will not qualify if you...
- History of prior surgical wound dehiscence or infection
- Allergy to suture material
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo neurosurgical cranial or spine procedures with wound closure using STRATAFIX sutures.
1 visit (in-person)
Duration - Up to 6 months
Participants are monitored for wound healing and complications after surgery.
Visits at 1, 3, and 6 months post-surgery
Trial Site Locations
Total: 1 location
1
University of Michigan Health Sparrow
Lansing, Michigan, United States, 48912
Actively Recruiting
Research Team
K
Karen Sagher
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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