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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01368991
• Date of registration: 03/06/2011
• Prospective Registration: Yes
• Primary sponsor: Cardiology Research UBC
• Public title: Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery Kryptonite
• Scientific title: Randomized Clinical Trial of Kryptonite for Prevention of Sternal Complications in High Risk Patients Undergoing Cardiac Surgery
• Date of first enrolment: July 2011
• Target sample size: 48
• Recruitment status: Not yet recruiting
• URL: http://clinicaltrials.gov/show/NCT01368991
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Richard Cook, MD

• Name: Richard Cook, MD, M.Sc, FRCSC
• Affiliation: Vancouver General Hospital

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Procedure: Conventional closure

Device: Kryptonite

Primary Outcome(s)

Quality of Life [Time Frame: Five Weeks]

Secondary Outcome(s)

Length of hospital stay [Time Frame: 5 weeks]

respiratory functions [Time Frame: 5 weeks]

pain [Time Frame: 5 weeks]

sternal complications [Time Frame: five weeks]

Secondary ID(s)

H11-00409

Source(s) of Monetary Support

Please refer to primary and secondary sponsors