Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fusion of Spine

Intervention / Treatment
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* Device: Barbed


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Suture<br>Standard suture for thoracolumbar fusion will be used per standard of care. | |
| Active Comparator: Stratafix Barbed Suture<br>Stratafix Barbed Suture for thoracolumbar fusion will be used. | Device: Barbed<br>* Barbed Suture<br>|

What is the study measuring?
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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 |