NCT03533595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

November 14, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2023

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

4.4 years

First QC Date

April 23, 2018

Last Update Submit

December 4, 2023

Conditions

Fusion of Spine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Safety evaluation of wound dehiscence

    Patient followed for 6 months from surgery

  • Safety evaluation of surgical site infection (SSI) rate

    Patient followed for 6 months from surgery

  • Safety evaluation of 30 days readmission rates

    Patient followed for 30 days from surgery

Study Arms (2)

Standard Suture

NO INTERVENTION

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

Stratafix Barbed Suture

ACTIVE COMPARATOR

Stratafix Barbed Suture for thoracolumbar fusion will be used.

Device: Barbed

Interventions

BarbedDEVICE

Barbed Suture

Stratafix Barbed Suture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 to 75 years old
  • Patients undergoing thoracolumbar fusion of at least 3 vertebral levels.
  • Patient able to sign informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

  • Joshua Heller, MD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 23, 2018

Study Start

November 14, 2018

Primary Completion

April 10, 2023

Study Completion

April 10, 2023

Last Updated

December 6, 2023

Record last verified: 2023-12

Locations

US(1)