Sternal Closure With Biologic Bone Cement in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National University Heart Centre, Singapore.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National University Heart Centre, Singapore
ClinicalTrials.gov Identifier:
NCT01261858
First received: December 15, 2010
Last updated: December 22, 2010
Last verified: November 2010
  Purpose

Median sternotomy has been the standard incision for coronary artery bypass grafting (CABG) in patients undergoing surgery for coronary artery disease. Given the increasing risk profile of contemporary cardiac surgery patients, sternal complications are subject to increase concomitantly. Despite advances in many areas of cardiac surgical procedures, innovation in sternal closure technique has been lacking and postoperative complications remain. In this study, the investigators aim to assess the effectiveness of using a novel osteoconductive biologic bone cement (KryptoniteTM, Doctors Research Group Inc.) as an adjunct to conventional sternal closure in post CABG patients having median sternotomy.

The outcomes of interest for this study will include: pain, discomfort, lung function, wound healing and analgesic use. The investigators assume that the use of KryptoniteTM will decrease postoperative pain leading to improvement in postoperative lung function. This may also lead to improvement in patient recovery and decrease in postoperative complications.

The investigators will undertake a single-blinded randomized, controlled study consisting of patients undergoing elective coronary artery bypass grafting (CABG) randomly assigned to either Group A (usual closure with stainless steel wires) or Group B (usual closure with stainless steel wires plus application of bone cement). Each group will consist of 64 patients in a total of 128 patients. Lung function data using a spirometer will be collected preoperatively and 3rd and 5th postoperative days as well as in outpatient clinic. Pain data will be collected on the 1st to 5th postoperative days.


Condition Intervention Phase
Sternal Closure
Device: Kryptonite
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Reinforced Sternal Closure Using Osteoconductive Biologic Bone Cement (Kryptonite) in Patients Undergoing Coronary Artery Bypass Grafting

Resource links provided by NLM:


Further study details as provided by National University Heart Centre, Singapore:

Primary Outcome Measures:
  • Change of lung function test values postoperatively compared to baseline value before surgery [ Time Frame: Preop, 3 POD, and 5 POD ] [ Designated as safety issue: No ]
    The investigators will evaluate the lung function preoperatively and postoperaatively by portable spirometer.


Secondary Outcome Measures:
  • Assessment of the change in the trend of improvement of pain score after sternal closure [ Time Frame: postoperatively, as in and outpatient ] [ Designated as safety issue: No ]
    The investigators will assess the pain score postoperatively


Estimated Enrollment: 64
Study Start Date: February 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stainless steel and Kryptonite
Sternal closure with stainless steel and kryptonite
Device: Kryptonite
osteoconductive biologic bone cement to be applied upon sternal closure
Other Name: Kryptonite
Active Comparator: Stainless steel
Sternal closure with only stainless steel
Device: Kryptonite
osteoconductive biologic bone cement to be applied upon sternal closure
Other Name: Kryptonite

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   50 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting for elective isolated on-pump CABG surgery using left internal mammary artery as a graft, through first-time median sternotomy aged between 50 and 79, who provide informed consent to participate.

Exclusion Criteria:

  • Patients who: are in emergent need for surgery, have had prior median sternotomy, are not applicable to the use of left internal mammary artery as a graft, are at high-risk of early post-operative bleeding requiring reopening of chest (taking anti-platelet medication within 24 hours of surgery), have had previous radiotherapy to the chest, present in a clinical preoperative state that suggests a prolonged recovery (e.g., other concurrent illness such as significant respiratory disease or renal failure requiring dialysis, current use of steroids, residence in a long-term care facility, current substance abuse), or present with cognitive impairment (e.g., confusion, dementia, Alzheimer's disease) that would preclude completion of survey questions, will be ineligible.
  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: NCT01261858

Contacts
Contact: Michael G Caleb, FRCS, FAMS +6567725217 michael_george_caleb@nuhs.edu.sg

Locations
Singapore
Department of Cardiac, Thoracic & Vascular Surgery, National University Heart Centre Not yet recruiting
Singapore, Singapore, 119228
Principal Investigator: Michael G Caleb, FRCS, FAMS         
Sub-Investigator: Atsuo Doi, MD         
Sub-Investigator: Vitaly Sorokin, MD, PhD         
Sub-Investigator: Chuen Neng Lee, FRCS, FRACS         
Sub-Investigator: Theodoros Kofidis, MD, PhD         
Sponsors and Collaborators
National University Heart Centre, Singapore
Investigators
Principal Investigator: Michael G Caleb, FRCS, FAMS Department of Cardiac, Thoracic & Vascular Surgery, National University Heart Centre, Singapore
  More Information

No publications provided

Responsible Party: Michael George Caleb, National University Heart Centre, Singapore
ClinicalTrials.gov Identifier: NCT01261858     History of Changes
Other Study ID Numbers: C/10/600
Study First Received: December 15, 2010
Last Updated: December 22, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Heart Centre, Singapore:
Sternal closure
Coronary artery bypass grafting
Biologic bone cement

ClinicalTrials.gov processed this record on October 23, 2014