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Sternotomy

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

Sponsored by Arthrex, Inc.

About this trial

Last updated 3 years ago

Study ID

US-19092

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. The subject is age 18 or over.

2. The subject has a planned full median sternotomy.

3. The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.

No

Exclusion Criteria

1. The subject is having a re-operative sternotomy.

2. The subject is having an emergency or salvage operation.

3. The subject has an unplanned sternotomy incision.

4. The subject had an incomplete sternotomy.

5. The subject has chronic pain syndromes or chronic narcotic administration.

6. The subject has a history of chest irradiation.

7. The subject is unwilling to comply with study follow-up visits and surveys.

8. The subject has a sternal infection or suspected sternal infection.

9. The subject has any known comorbidity that will influence the outcomes.

10. The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).

Locations

Location

Status