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

NCT07225101 | Recruiting Phase 4 FDA Device

• 1 other identifier: HUM00268953
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Superficial surgical site infection; Suture material; Wound closure techniques; brain tumor; spine; spine trauma; neurosurgery; hemorrhagic stroke; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score

  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.

  1 month

Secondary Outcomes (8)

• Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score

  3 and 6 months

• The Wound-Quality of Life (QOL) questionnaire score

  1, 3 and 6 months

• Intraoperative time required for wound closure

  Immediately following surgery

• Percent of participants positive for superficial surgical site infection (SSI)

  Up to six months

• Number of case deviations and descriptions from prescribed suturing paradigm

  Immediately following surgery

Study Arms (1)

STRATAFIX PDS and Monocryl suture

EXPERIMENTAL

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

Device: STRATAFIX PDS and Monocryl suture

Interventions

STRATAFIX PDS and Monocryl suture DEVICE

STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.

STRATAFIX PDS and Monocryl suture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective or emergent surgical approaches for cranial or spine neurosurgical approaches, requiring sutures for wound closure, requiring multilayer wound closure

You may not qualify if:

• Patients with prior surgical wound dehiscence or infection
• Patients with allergy to suture material

Sponsors & Collaborators

• University of Michigan: lead
• Johnson & Johnson: collaborator

Study Sites (1)

University of Michigan Health Sparrow

Lansing, Michigan, 48912, United States

RECRUITING

MeSH Terms

Conditions

Hemorrhagic Stroke; Brain Injuries, Traumatic; Brain Neoplasms

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Michael Karsy, MD, PhD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Sagher

CONTACT

734-232-4843; kfrisch@med.umich.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Clinical Professor of Neurosurgery

Model Details: Open label, single-arm, non-crossover prospective cohort study with non-inferiority statistical analysis.

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 5, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2025

Record last verified: 2025-11

Locations

US (1)