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 period of time. This research will provide additional information about using STRATAFIX sutures to close surgical wounds.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury; Spine; Brain Tumor Adult; Wound Closure; Hemorrhagic Stroke, Intracerebral; Neurovascular
• Intervention / Treatment: Device: STRATAFIX PDS and Monocryl suture

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Karen Sagher; Phone Number: 734-232-4843; Email: kfrisch@med.umich.edu

Study Locations

• United States
  • Michigan
    • Lansing, Michigan, United States, 48912
      • Recruiting
      • University of Michigan Health Sparrow
      • Contact: Karen Sagher; Phone Number: 734-232-4843; Email: kfrisch@med.umich.edu
      • Principal Investigator: Michael Karsy, MD, PhD, MSc
      • Sub-Investigator: Nasser M Yaghi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STRATAFIX PDS and Monocryl suture; All participants enrolled will have their scheduled surgery as planned with their wound closed using STRATAFIX.	Device: STRATAFIX PDS and Monocryl suture; STRATAFIX, suture employs a novel incorporation of barbed components to suture resulting in tension holding closure with long-lasting absorbable suture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. Scores will be separated into specific patient subgroups (e.g., spine procedures vs. cranial procedures, younger vs. older patients)	3 and 6 months
The Wound-Quality of Life (QOL) questionnaire score	This is a 17-point scale with 5 choices each ranging from 17-85. Higher scores indicate worse quality of life.	1, 3 and 6 months
Intraoperative time required for wound closure	Time for intraoperative wound closure will be monitored. Wound closure technique will be video recorded.	Immediately following surgery
Percent of participants positive for superficial surgical site infection (SSI)	Assessed using a culture or polymerase chain reaction	Up to six months
Number of case deviations and descriptions from prescribed suturing paradigm	A quantification and description for additional suture material required for surgical procedures will be monitored.	Immediately following surgery
Liker scale of patient satisfaction with wound	10 point subjective scale indicating patient satisfaction with wound	1, 3 and 6 months
Wound imaging at perioperative followup	Wound pictures during followup period.	1, 3 and 6 months
Wound revision strategy	Description of any wound revision strategies and timing	up to 6 months

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Johnson & Johnson
• Investigators: Principal Investigator: Michael Karsy, MD, PhD, MSc, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 3, 2025
• First Submitted That Met QC Criteria: November 3, 2025
• First Posted (Estimated): November 5, 2025

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: November 3, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: traumatic brain injury; brain tumor; spine; neurosurgery; hemorrhagic stroke; Suture material; Superficial surgical site infection; Wound closure techniques; spine trauma
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Neoplasms by Site; Neoplasms; Nervous System Neoplasms; Craniocerebral Trauma; Trauma, Nervous System; Central Nervous System Neoplasms; Stroke; Brain Injuries; Brain Injuries, Traumatic; Hemorrhagic Stroke; Brain Neoplasms
• Other Study ID Numbers: HUM00268953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Unclear if manuscript will be published in an ICMJE journal and data from this study are restricted from the University of Michigan Data Use Committee

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No