Clinical trial NCT03533595: Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery
Official title: Prospective Analysis of STRATAFIX Symmetric PDS Plus Suture for Fascial Closure in Spinal Surgery; Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fusion of Spine
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Ethicon, Inc.
First posted: 2018-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduced operating times
timeFrame: Patient followed for 6 months from surgery
Secondary outcomes:
measure: Safety evaluation of wound dehiscence
timeFrame: Patient followed for 6 months from surgery
measure: Safety evaluation of surgical site infection (SSI) rate
timeFrame: Patient followed for 6 months from surgery
measure: Safety evaluation of 30 days readmission rates
timeFrame: Patient followed for 30 days from surgery
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Joshua Heller, MD
role: PRINCIPAL_INVESTIGATOR
References: