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

NCT01261858 | Unknown Phase 4

• 1 other identifier: C/10/600
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sternal Closure

Keywords

Sternal closure; Coronary artery bypass grafting; Biologic bone cement

Outcome Measures

Primary Outcomes (1)

• Change of lung function test values postoperatively compared to baseline value before surgery

  The investigators will evaluate the lung function preoperatively and postoperaatively by portable spirometer.

  Preop, 3 POD, and 5 POD

Secondary Outcomes (1)

• Assessment of the change in the trend of improvement of pain score after sternal closure

  postoperatively, as in and outpatient

Study Arms (2)

Stainless steel and Kryptonite

EXPERIMENTAL

Sternal closure with stainless steel and kryptonite

Device: Kryptonite

Stainless steel

ACTIVE COMPARATOR

Sternal closure with only stainless steel

Device: Kryptonite

Interventions

Kryptonite DEVICE

osteoconductive biologic bone cement to be applied upon sternal closure

Stainless steel; Stainless steel and Kryptonite

Eligibility Criteria

• Age: 50 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Heart Centre, Singapore: lead

Study Sites (1)

Department of Cardiac, Thoracic & Vascular Surgery, National University Heart Centre

Singapore, 119228, Singapore

Location

Study Officials

• Michael G Caleb, FRCS, FAMS

  Department of Cardiac, Thoracic & Vascular Surgery, National University Heart Centre, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael G Caleb, FRCS, FAMS

CONTACT

+6567725217; michael_george_caleb@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: December 23, 2010

Record last verified: 2010-11

Locations

SG (1)