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

NCT04743895 | Completed FDA Device

• 1 other identifier: US-19092
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.

Conditions

Sternotomy

Outcome Measures

Primary Outcomes (1)

• Progression of sternal healing

  A CT scan will be used to assess sternal healing. Axial slices will be analyzed at 5 locations along the sternum using a 6 point quantitative scale. (0-no healing, 1- minimal healing, 2-mild healing, 3-moderate healing, 4-partial synthesis, 5-complete synthesis).

  3 months post-operative

Secondary Outcomes (4)

• Complication rate

  Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months

• Visual Analog Scale (VAS)

  Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months

• Veteran's Rand Health Survey

  Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months

• Analgesic medication Log

  Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.

Study Arms (2)

Stainless Steel Wire Cerclage

ACTIVE COMPARATOR

Sternotomy closure using Stainless Steel Wire Cerclage

Device: Stainless Steel Wire Cerclage

FiberTape Cerclage

ACTIVE COMPARATOR

Sternotomy closure using FiberTape

Device: Stainless Steel Wire Cerclage

Interventions

Stainless Steel Wire Cerclage DEVICE

Wire cerclage used to close sternum after cardiothoracic surgery.

FiberTape Cerclage; Stainless Steel Wire Cerclage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (1)

Lee Memorial Health System

Fort Myers, Florida, 33908, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant is blinded to study treatment and radiographers that assess CT scans are also blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Single Blinded Study

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 8, 2021
• Study Start: January 4, 2021
• Primary Completion: May 6, 2022
• Study Completion: May 6, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)