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NCT07225101 | RECRUITING | Wound Closure


Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Sponsor:

University of Michigan

Information provided by (Responsible Party):

Michael Karsy

Brief 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.

Condition or disease

Wound Closure

Brain Tumor Adult

Spine

Neurovascular

Hemorrhagic Stroke, Intracerebral

Traumatic Brain Injury

Intervention/treatment

STRATAFIX PDS and Monocryl suture

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 160 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures
Actual Study Start Date : 2025-11-01
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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

Evaluation of the Efficacy of STRATAFIX for Neurosurgical Cranial and Spine Procedures

Location Details

NCT07225101


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, road cancer

University of Michigan Health Sparrow

Lansing, road cancer, United States, 48912

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