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Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

NCT ID: NCT03533595

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-14

Study Completion Date

2023-04-10

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.

Conditions

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Fusion of Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Suture

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Stratafix Barbed Suture

Stratafix Barbed Suture for thoracolumbar fusion will be used.

Group Type ACTIVE_COMPARATOR

Barbed

Intervention Type DEVICE

Barbed Suture

Interventions

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Barbed

Barbed Suture

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ethicon, Inc.

INDUSTRY

Sponsor Role collaborator

Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Heller, MD

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

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Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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17C.580

Identifier Type: -

Identifier Source: org_study_id