Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

Prospective Analysis of STRATAFIX Symmetric PDS Plus Suture for Fascial Closure in Spinal Surgery; Pilot Study

STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure following spinal surgery. A pilot study will aide in the design of a larger randomized controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures versus traditional Vicryl sutures.

Study Overview

• Status: Completed
• Conditions: Fusion of Spine
• Intervention / Treatment: Device: Barbed

Detailed Description

Effective and secure suture is integral in spinal surgery, creating a strong barrier for tissue repair and a seal which prevents infection of the surgical site. The goal of any suture is to close the wound while minimizing risks of complications such as wound dehiscence and surgical site infection . A new type of suture, barbed suture, uses integrated barbs to secure the suture to the tissue without requiring knots for fixation. The result is a suture that evenly distributes tension along the length of the incision, while requiring less time to close . Additionally, STRATAFIX sutures offer a "Plus" antibacterial option for their knotless sutures, which further increases the safety and efficacy of this product.

Barbed suture technologies have been utilized in a variety of specialties, but neurosurgery remains unstudied in this respect. The primary aim of this study is to assess the time to closure using STRATAFIX technology. Decreased time to closure directly translates into decreased operating room time, and thus increased savings, especially for high-volume institutions. The secondary aim of this study is to determine the risk for surgical complications using STRATAFIX. Previous studies in other specialties have shown no significant difference in rate of adverse consequences when utilizing barbed sutures. To assess this aim, patients will be evaluated for wound dehiscence, SSI, deep infection, and 30-day rate of readmission for wound infection.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18 to 75 years old
2. Patients undergoing thoracolumbar fusion of at least 3 vertebral levels.
3. Patient able to sign informed consent.

Exclusion Criteria:

1. Current infection (osteomyelitis), diabetes, severely malnourished or other co-morbidities that the investigator believes does not make the patient a good candidate for surgery.
2. Patients with incidental durotomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Suture; Standard suture for thoracolumbar fusion will be used per standard of care.
Active Comparator: Stratafix Barbed Suture; Stratafix Barbed Suture for thoracolumbar fusion will be used.	Device: Barbed; Barbed Suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduced operating times	STRATAFIX Symmetric PDS Plus sutures will reduce the time required for fascial closure following spinal surgery. A pilot study will aide in the design of a larger randomized controlled trial to compare suture closure time of the STRATAFIX Symmetric PDS Plus sutures versus traditional Vicryl sutures.	Patient followed for 6 months from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety evaluation of wound dehiscence	Subject's surgical site wound will be monitored during the protocol defined time points.	Patient followed for 6 months from surgery
Safety evaluation of surgical site infection (SSI) rate	Subject's surgical site will be monitored and assessed for infection during the protocol defined time points.	Patient followed for 6 months from surgery
Safety evaluation of 30 days readmission rates	Subject will be monitored for 30 days post surgery for AE's and SAE's which result in readmission to the hospital.	Patient followed for 30 days from surgery

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Ethicon, Inc.
• Investigators: Principal Investigator: Joshua Heller, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2018
• Primary Completion (Actual): April 10, 2023
• Study Completion (Actual): April 10, 2023

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 23, 2018

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17C.580

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes