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Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone

NCT04743895 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-06-21

No results posted yet for this study

Summary

This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.

Conditions

  • Sternotomy

Interventions

DEVICE

Stainless Steel Wire Cerclage

Wire cerclage used to close sternum after cardiothoracic surgery.

Sponsors & Collaborators

  • Arthrex, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-04
Primary Completion
2022-05-06
Completion
2022-05-06
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 NCT04743895 on ClinicalTrials.gov