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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01368991
Recruitment Status : Unknown
Verified April 2011 by Cardiology Research UBC.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2011
Last Update Posted : June 8, 2011
Information provided by:
Cardiology Research UBC

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Kryptonite Procedure: Conventional closure Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery
Study Start Date : July 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: Five Weeks ]

Secondary Outcome Measures :
  1. Length of hospital stay [ Time Frame: 5 weeks ]
  2. pain [ Time Frame: 5 weeks ]
  3. sternal complications [ Time Frame: five weeks ]
  4. respiratory functions [ Time Frame: 5 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01368991

Contact: Richard Cook, MD 604-806-9601
Contact: Naomi Uchida, RN 604-875-4521

Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Cardiology Research UBC
Principal Investigator: Richard Cook, MD, M.Sc, FRCSC Vancouver General Hospital

Responsible Party: Dr. Richard Cook, University of British Columbia Identifier: NCT01368991     History of Changes
Other Study ID Numbers: H11-00409
First Posted: June 8, 2011    Key Record Dates
Last Update Posted: June 8, 2011
Last Verified: April 2011

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

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