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

Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage

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.

Study Overview

• Status: Completed
• Conditions: Sternotomy
• Intervention / Treatment: Device: Stainless Steel Wire Cerclage

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 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).

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Fort Myers, Florida, United States, 33908
      • Lee Memorial Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stainless Steel Wire Cerclage; Sternotomy closure using Stainless Steel Wire Cerclage	Device: Stainless Steel Wire Cerclage; Wire cerclage used to close sternum after cardiothoracic surgery.
Active Comparator: FiberTape Cerclage; Sternotomy closure using FiberTape	Device: Stainless Steel Wire Cerclage; Wire cerclage used to close sternum after cardiothoracic surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Device related adverse event collection	Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months
Visual Analog Scale (VAS)	Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0 being no pain to 10 being worst pain.	Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Veteran's Rand Health Survey	Patient reported physical and mental health survey. Answers are summarized into 2 scores, a physical component score (PCS) and a mental component score (MCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.	Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Analgesic medication Log	Analgesic use for sternal pain will be collected on a medication log, tracking type of pain medication, dose and start and ends dates.	Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.

Collaborators and Investigators

• Sponsor: Arthrex, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 15, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: US-19092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes