A Study of Sternal Closure After Open Heart Surgery: Rigid Versus Wire Closure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Thomas Jefferson University
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT01317095
First received: March 10, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

The investigators are conducting this research to compare two different methods of closure of the sternum after cardiac surgery to determine if one method is better than the other. Open heart surgery always requires a sternotomy, and at the end of surgery the sternum needs to be closed. The sternum can be closed with Stainless Steel Wires or Sternalock rigid sternal closure system with equivocal results; however, the outcomes of these two methods have never been investigated in a randomized study. Thus, the investigators are conducting this study to compare two different methods of closure if one method demonstrates any recovery benefit over the other, using randomizing the subjects 1:1 to either rigid fixation with Sternalock or stainless steel wire closure. Recover benefit will be measured by postoperative intubation time, length of intensive care unit stay, and overall postoperative length of stay


Condition Intervention
Pain
Device: Sternalock Rigid Fixation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study of Two Types of Sternal Closure After Open Heart Surgery: Rigid Sternal Fixation vs. Sternal Wire Closure

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Intubation time [ Time Frame: 48 hours after surgery ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine if rigid sternal fixation can shorten the postoperative intubation time after open heart surgery compared to the wire closure


Secondary Outcome Measures:
  • Length of ICU stay, hospital stay and pain scores. [ Time Frame: 1 month after surgery ] [ Designated as safety issue: Yes ]
    The secondary objectives are to trend length of postoperative intensive care unit stay and postoperative length of hospital stay. We will also monitor the patient's pain scores and any incidences of sternal infection, sternal dehiscence, and pneumonia.


Estimated Enrollment: 200
Study Start Date: March 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Wire closure is the intervention
Patients will have their sternum closed using stainless steel wires.
Device: Sternalock Rigid Fixation
Patients will have their sternum closed by rigid fixation using Sternalock plates.
Active Comparator: Rigid fixation
Patients will have their sternum closed by rigid fixation using Starnalock plates.
Device: Sternalock Rigid Fixation
Patients will have their sternum closed by rigid fixation using Sternalock plates.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
  2. patient age ≥18 and <80 .
  3. patient undergoing elective surgery.
  4. patient undergoing urgent surgery (defined as surgery scheduled while the patient is in the hospital and performed during the same hospital admission with stable medical condition)
  5. patients who is willing to sign the informed consent to participate the study.

Exclusion Criteria:

Pre- operative exclusion criteria:

  1. patient undergoing redo-sternotomy.
  2. patient undergoing emergent surgery (defined as life-threating or unstable condition requiring surgery on the same day of the surgical consultation.)
  3. patients on dialysis
  4. patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
  5. patients with body mass index ≥ 40.
  6. patients with active endocarditis.
  7. patients with known metal allergy.
  8. patient who refuses consent.
  9. patient who is unable to follow the postoperative instructions.

Intraoperative exclusion criteria:

  1. osteoporosis or poor quality of sternum.
  2. unstable sternal fracture.
  3. sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
  4. bilateral mammary artery harvest (causing poor blood supply to the sternum).
  5. patients in whom the chest needs to be left open due to medical reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317095

Contacts
Contact: Hitoshi Hirose, MD, PhD 215-955-5654 genex@nifty.com
Contact: James T Diehl, MD 215-955-5654 James.Diehl@jefferson.edu

Locations
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Phialdelphia, Pennsylvania, United States, 19107
Contact: Hitoshi Hirose, MD, PhD    215-955-5654    genex@nifty.com   
Contact: James T Diehl, MD    215-955-5654    James.Diehl@jefferson.edu   
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Hitoshi Hirose, MD, PhD Thomas Jefferson University
  More Information

Additional Information:
No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01317095     History of Changes
Other Study ID Numbers: Sternal Closure
Study First Received: March 10, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Rigid fixation
Sternal closure
Open heart surgery

ClinicalTrials.gov processed this record on August 28, 2014