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NCT Number: NCT04743895

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

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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Key information

Conditions

Sternotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lee Memorial Health System

Fort Myers, Florida, 33908, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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).

Treatment and study plan

Stainless Steel Wire Cerclage

Device

Wire cerclage used to close sternum after cardiothoracic surgery.

Primary outcomes

  1. Progression of sternal healing

    Time frame: 3 months post-operative

    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).

Secondary outcomes

  1. Complication rate

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

    Device related adverse event collection

  2. Visual Analog Scale (VAS)

    Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months

    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.

  3. Veteran's Rand Health Survey

    Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months

    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.

  4. Analgesic medication Log

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

    Analgesic use for sternal pain will be collected on a medication log, tracking type of pain medication, dose and start and ends dates.

Sponsors and collaborators

Lead sponsor

Arthrex, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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