Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

Fusion of Spine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03533595
• Other study ID #: 17C.580
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: April 10, 2023

Study information

• Verified date: December 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fusion of Spine

Intervention

Device:
• Barbed
Barbed Suture

Locations

Country	Name	City	State
United States	Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Thomas Jefferson University	Ethicon, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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