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Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery

This study is not yet open for participant recruitment.
Verified April 2011 by Interventional Cardiology Research
Sponsor:
Information provided by:
Interventional Cardiology Research
ClinicalTrials.gov Identifier:
NCT01368991
First received: June 3, 2011
Last updated: June 7, 2011
Last verified: April 2011
History of Changes
  Purpose

Kryptonite is a non-toxic biologic polymer, that has previously been used in orthopedic surgery. The objective of our study is to demonstrate the benefits of Kryptonite in cardiac surgery patients at high risk for sternal wound complications. The investigators have designed a randomized clinical trial of 48 high risk patients, with a 1:2 randomization of kryptonite to conventional closure. The primary outcome will be quality of life. Secondary outcomes include sternal complications, pain, hospital length of stay, and respiratory function.


Condition Intervention Phase
Coronary Artery Disease
 Device: Kryptonite
Procedure: Conventional closure
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Interventional Cardiology Research:

Primary Outcome Measures:
  • Quality of Life [ Time Frame: Five Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of hospital stay [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • pain [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
  • sternal complications [ Time Frame: five weeks ] [ Designated as safety issue: No ]
  • respiratory functions [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Kryptonite
Sternal closure with stainless steel and kryptonite
 Device: Kryptonite
Osteoconductive biologic bone cement to be applied upon sternal closure
Active Comparator: Conventional Closure
Sternal closure with stainless steel wires
 Procedure: Conventional closure
conventional closure, no kryptonite applied

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • To be included in the study, patients must satisfy ONE of the following criteria:

    1. Body mass index (BMI) > 30kg/m2 AND at least one other risk factor. Additional risk factors include insulin dependent diabetes ≥ 5 years, active smoking until time of hospitalization, chronic obstructive pulmonary disease, long-term steroid use equivalent to ≥ 5mgof prednisone daily for > 1 month pre-operatively, alcohol/drug abuse, and mobilization with aid of a walker, cane, scooter, etc.
    2. BMI > 40kg/m2
    3. Limited mobility with dependence on upper body for mobilization.

Exclusion Criteria:

  • age <18 years
  • cardiac surgery through incision other than sternotomy
  • emergent surgery
  • previous sternotomy (i.e. redo cardiac surgery)
  • surgery for sternal dehiscence or mediastinitis, and
  • inability to obtain informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01368991

Contacts
Contact: Richard Cook, MD 604-806-9601 richard.cook@vch.ca
Contact: Naomi Uchida, RN 604-875-4521 nuchida@interchange.ubc.ca

Locations
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Interventional Cardiology Research
Investigators
Principal Investigator: Richard Cook, MD, M.Sc, FRCSC Vancouver General Hospital
  More Information

No publications provided

Responsible Party: Dr. Richard Cook, University of British Columbia
ClinicalTrials.gov Identifier: NCT01368991     History of Changes
Other Study ID Numbers: H11-00409
Study First Received: June 3, 2011
Last Updated: June 7, 2011
Health Authority: Canada: Health Canada

Keywords provided by Interventional Cardiology Research:
Coronary Artery Bypass Grafts
Sternal Closure
Biologic Bone cement

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013