Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03533595 |
Other study ID # |
17C.580 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.