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

NCT01368991 | Unknown Phase 3 DMC

• 1 other identifier: H11-00409
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafts; Sternal Closure; Biologic Bone cement

Outcome Measures

Primary Outcomes (1)

• Quality of Life

  Five Weeks

Secondary Outcomes (4)

• Length of hospital stay

  5 weeks

• pain

  5 weeks

• sternal complications

  five weeks

• respiratory functions

  5 weeks

Study Arms (2)

Kryptonite

ACTIVE COMPARATOR

Sternal closure with stainless steel and kryptonite

Device: Kryptonite

Conventional Closure

ACTIVE COMPARATOR

Sternal closure with stainless steel wires

Procedure: Conventional closure

Interventions

Kryptonite DEVICE

Osteoconductive biologic bone cement to be applied upon sternal closure

Kryptonite

Conventional closure PROCEDURE

conventional closure, no kryptonite applied

Conventional Closure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included in the study, patients must satisfy ONE of the following criteria:
• 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.
• BMI \> 40kg/m2
• Limited mobility with dependence on upper body for mobilization.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiology Research UBC: lead

Study Sites (1)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Richard Cook, MD, M.Sc, FRCSC

  Vancouver General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Cook, MD

CONTACT

604-806-9601; richard.cook@vch.ca

Naomi Uchida, RN

CONTACT

604-875-4521; nuchida@interchange.ubc.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 8, 2011
• Study Start: July 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: July 1, 2013
• Last Updated: June 8, 2011

Record last verified: 2011-04

Locations

CA (1)