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Recruiting NCT07225101

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

Phase IV Interventional Wound Closure Brain Tumor Adult Spine Neurovascular

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STRATAFIX PDS and Monocryl suture.
Who it may be relevant to
Registry conditions: Wound Closure, Brain Tumor Adult, Spine, Neurovascular. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score [Time frame: 1 month]
Secondary outcome measures (8)
  • Wound complications Bates-Jensen Wound Assessment Tool (BWAT) score [Time frame: 3 and 6 months]
  • The Wound-Quality of Life (QOL) questionnaire score [Time frame: 1, 3 and 6 months]
  • Intraoperative time required for wound closure [Time frame: Immediately following surgery]
  • Percent of participants positive for superficial surgical site infection (SSI) [Time frame: Up to six months]
  • Number of case deviations and descriptions from prescribed suturing paradigm [Time frame: Immediately following surgery]
  • Liker scale of patient satisfaction with wound [Time frame: 1, 3 and 6 months]
  • Wound imaging at perioperative followup [Time frame: 1, 3 and 6 months]
  • Wound revision strategy [Time frame: up to 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan Health Sparrow — Lansing

Identifiers

NCT: NCT07225101 · HUM00268953

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗