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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-05-06

Brief Summary

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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.

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Detailed Description

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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 midline sternal closure with stainless steel wire.

The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.

CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis).

All adverse events related to the sternal closure procedure or the devices used for closure will be collected.

Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).

Conditions

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Sternotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, Single Blinded Study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Participant is blinded to study treatment and radiographers that assess CT scans are also blinded.

Study Groups

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Stainless Steel Wire Cerclage

Sternotomy closure using Stainless Steel Wire Cerclage

Group Type ACTIVE_COMPARATOR

Stainless Steel Wire Cerclage

Intervention Type DEVICE

Wire cerclage used to close sternum after cardiothoracic surgery.

FiberTape Cerclage

Sternotomy closure using FiberTape

Group Type ACTIVE_COMPARATOR

Stainless Steel Wire Cerclage

Intervention Type DEVICE

Wire cerclage used to close sternum after cardiothoracic surgery.

Interventions

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Stainless Steel Wire Cerclage

Wire cerclage used to close sternum after cardiothoracic surgery.

Intervention Type DEVICE

Eligibility Criteria

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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.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No