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Comparative Analysis of Sutures for Fascial Closure in Spinal Surgery

NCT03533595 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-12-06

No results posted yet for this study

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.

Conditions

  • Fusion of Spine

Interventions

DEVICE

Barbed

Barbed Suture

Sponsors & Collaborators

  • Ethicon, Inc.

    collaborator INDUSTRY

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Joshua Heller, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2023-04-10
Completion
2023-04-10
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533595 on ClinicalTrials.gov