Status:
COMPLETED
Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone
Lead Sponsor:
Arthrex, Inc.
Conditions:
Sternotomy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent mid...
Eligibility Criteria
Inclusion
- The subject is age 18 or over.
- The subject has a planned full median sternotomy.
- The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.
Exclusion
- The subject is having a re-operative sternotomy.
- The subject is having an emergency or salvage operation.
- The subject has an unplanned sternotomy incision.
- The subject had an incomplete sternotomy.
- The subject has chronic pain syndromes or chronic narcotic administration.
- The subject has a history of chest irradiation.
- The subject is unwilling to comply with study follow-up visits and surveys.
- The subject has a sternal infection or suspected sternal infection.
- The subject has any known comorbidity that will influence the outcomes.
- The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04743895
Start Date
January 4 2021
End Date
May 6 2022
Last Update
June 21 2022
Active Locations (1)
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1
Lee Memorial Health System
Fort Myers, Florida, United States, 33908