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

University of Michigan

Status and phase: Enrolling; Phase 4

Conditions: Hemorrhagic Stroke, Intracerebral; Wound Closure; Traumatic Brain Injury; Neurovascular; Brain Tumor Adult; Spine

Treatments: Device: STRATAFIX PDS and Monocryl suture

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07225101

HUM00268953

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

STRATAFIX PDS and Monocryl suture

Experimental group

Description:

All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.

Treatment:

Device: STRATAFIX PDS and Monocryl suture