Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

Thomas Jefferson University

Status: Completed

Conditions: Fusion of Spine

Treatments: Device: Barbed

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03533595

17C.580

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Standard Suture

No Intervention group

Description:

Standard suture for thoracolumbar fusion will be used per standard of care.

Stratafix Barbed Suture

Active Comparator group

Description:

Stratafix Barbed Suture for thoracolumbar fusion will be used.

Treatment:

Device: Barbed