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Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

NCT03289104 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-12-17

No results posted yet for this study

Summary

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postoperative pain.

Conditions

  • Sternal Injury
  • Cardiac Surgery
  • Heart Diseases

Interventions

DEVICE

Steel Wires

Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.

DEVICE

ZipFix Sternal Closure System

Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.

Sponsors & Collaborators

  • Ottawa Heart Institute Research Corporation

    lead OTHER

Principal Investigators

  • Marc Ruel, MD, MPH · Ottawa Heart Institute Research Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • Canada

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 NCT03289104 on ClinicalTrials.gov