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Completed

NCT Number: NCT03533595

Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Barbed

Device

Barbed Suture

Primary outcomes

  1. Reduced operating times

    Time frame: Patient followed for 6 months from surgery

    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.

Secondary outcomes

  1. Safety evaluation of wound dehiscence

    Time frame: Patient followed for 6 months from surgery

    Subject's surgical site wound will be monitored during the protocol defined time points.

  2. Safety evaluation of surgical site infection (SSI) rate

    Time frame: Patient followed for 6 months from surgery

    Subject's surgical site will be monitored and assessed for infection during the protocol defined time points.

  3. Safety evaluation of 30 days readmission rates

    Time frame: Patient followed for 30 days from surgery

    Subject will be monitored for 30 days post surgery for AE's and SAE's which result in readmission to the hospital.

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • Ethicon, Inc.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 23, 2018
Registry last updated
Dec 6, 2023

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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