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

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ClinicalTrials.gov Identifier: NCT01317095
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Device: Sternalock Rigid Fixation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2011
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Intubation Time [ Time Frame: 48 hours after surgery ]
    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 :
  1. Pain Scores. [ Time Frame: 5 days after surgery ]
    One of the secondary outcomes are monitoring the patient's pain scores from postoperative day 1 till day 5.

  2. Length of ICU Stay [ Time Frame: ICU stay ]
    Length of postoperative intensive care unit stay.

  3. Postop Length of Hospital Stay. [ Time Frame: Until hospital discharge ]
    Postoperative length of hospital stay.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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-threatening 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317095


Locations
United States, Pennsylvania
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Hitoshi Hirose, MD, PhD Thomas Jefferson University

Additional Information:
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT01317095     History of Changes
Other Study ID Numbers: Sternal Closure
First Posted: March 17, 2011    Key Record Dates
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018
Last Verified: January 2018

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