NCT01317095

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

January 1, 2018

Enrollment Period

5.3 years

First QC Date

March 10, 2011

Results QC Date

October 18, 2017

Last Update Submit

January 16, 2018

Conditions

Pain

Keywords

Rigid fixationSternal closureOpen heart surgery

Outcome Measures

Primary Outcomes (1)

  • Intubation Time

    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

    48 hours after surgery

Secondary Outcomes (3)

  • Pain Scores.

    5 days after surgery

  • Length of ICU Stay

    ICU stay

  • Postop Length of Hospital Stay.

    Until hospital discharge

Study Arms (2)

Wire closure is the intervention

ACTIVE COMPARATOR

Patients will have their sternum closed using stainless steel wires.

Device: Sternalock Rigid Fixation

Rigid fixation

ACTIVE COMPARATOR

Patients will have their sternum closed by rigid fixation using Starnalock plates.

Device: Sternalock Rigid Fixation

Interventions

Sternalock Rigid FixationDEVICE

Patients will have their sternum closed by rigid fixation using Sternalock plates.

Rigid fixationWire closure is the intervention

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • scheduled (elective or urgent) coronary artery bypass graft with or without valvular surgery by our cardiothoracic surgery division.
  • patient age ≥18 and \<80 .
  • patient undergoing elective surgery.
  • 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)
  • patients who is willing to sign the informed consent to participate the study.

You may not qualify if:

  • patient undergoing redo-sternotomy.
  • patient undergoing emergent surgery (defined as life-threatening or unstable condition requiring surgery on the same day of the surgical consultation.)
  • patients on dialysis
  • patients undergoing ventricular assist device insertion, transplant surgery, or aortic surgery.
  • patients with body mass index ≥ 40.
  • patients with active endocarditis.
  • patients with known metal allergy.
  • patient who refuses consent.
  • patient who is unable to follow the postoperative instructions.
  • osteoporosis or poor quality of sternum.
  • unstable sternal fracture.
  • sternum too thin (less than 4 mm) or too thick (greater than 14 mm) as determined by direct measurement.
  • bilateral mammary artery harvest (causing poor blood supply to the sternum).
  • patients in whom the chest needs to be left open due to medical reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Small number of enrollment.

Results Point of Contact

Title
Hitoshi Hirose, Professor of Surgery
Organization
Thomas Jefferson University
Hitoshi.Hirose@jefferson.edu
2159556925

Study Officials

  • Hitoshi Hirose, MD, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2011

First Posted

March 17, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2016

Study Completion

September 1, 2016

Last Updated

February 14, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-01

Locations

US(1)