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NCT Number: NCT07225101

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.

Recruiting

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Key information

Conditions

Wound Closure Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Neoplasms Brain Tumor Adult Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Craniocerebral Trauma Hemorrhagic Stroke Hemorrhagic Stroke, Intracerebral Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurovascular Spine Stroke Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Michigan Health Sparrow

Lansing, Michigan, 48912, United States

Location status: Recruiting

Location contact

Karen Sagher

CONTACT

[email protected]

734-232-4843

Michael Karsy, MD, PhD, MSc

PRINCIPAL_INVESTIGATOR

Nasser M Yaghi, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score

    Time frame: 1 month

    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.

Secondary outcomes

  1. Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score

    Time frame: 3 and 6 months

    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)

  2. The Wound-Quality of Life (QOL) questionnaire score

    Time frame: 1, 3 and 6 months

    This is a 17-point scale with 5 choices each ranging from 17-85. Higher scores indicate worse quality of life.

  3. Intraoperative time required for wound closure

    Time frame: Immediately following surgery

    Time for intraoperative wound closure will be monitored. Wound closure technique will be video recorded.

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

    Time frame: Up to six months

    Assessed using a culture or polymerase chain reaction

  5. Number of case deviations and descriptions from prescribed suturing paradigm

    Time frame: Immediately following surgery

    A quantification and description for additional suture material required for surgical procedures will be monitored.

  6. Liker scale of patient satisfaction with wound

    Time frame: 1, 3 and 6 months

    10 point subjective scale indicating patient satisfaction with wound

  7. Wound imaging at perioperative followup

    Time frame: 1, 3 and 6 months

    Wound pictures during followup period.

  8. Wound revision strategy

    Time frame: up to 6 months

    Description of any wound revision strategies and timing

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Sagher

CONTACT

[email protected]

734-232-4843

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Johnson & Johnson

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 5, 2025
Registry last updated
Nov 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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