Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX (Closure)

University of Ottawa Heart Institute

Status

Withdrawn

Conditions

Cardiac Surgery

Sternal Injury

Heart Diseases

Treatments

Device: Steel Wires

Device: ZipFix Sternal Closure System

Study type

Interventional

Funder types

Other

Identifiers

NCT03289104

20160921

Details and patient eligibility

About

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decreased postoperative pain.

Full description

Despite a longer time for bone healing and functional recovery, median sternotomy is still the most common approach in cardiac surgery. Sternal closure has traditionally been wire cerclage using stainless steel wires, however, new sternal fixation devices have been developed to improve sternal union. Rigid sternal fixation, although very costly, has demonstrated to be superior to standard wire cerclage both in clinical and biomechanical studies. Although improved sternal healing was observed with rigid plate fixation in a randomized controlled trial in high risk patients, the wound complication rate with plate fixation was almost double that of wire cerclage albeit not statistically significant.

A novel sternal closure system denoted the sternal ZIPFIX system (DePuySynthes, Companies of Johnson and Johnson, West Over, PA, US) is biocompatible Poly-Ether-Ether-Ketone implant that was developed for fast and reliable sternal fixation following median sternotomy. First published case series utilized the sternal ZIPFIX System demonstrating effective sternal stability at 30 days. Another study has demonstrated no significant difference in the incidence of sternal wound infection following the ZIPFIX system compared to standard wire cerclage while Stelly et al., 2015 demonstrated reduced risk of deep sternal wound infection for patients using ZIPFIX. The ZIPFIX system demonstrates a higher resistance of fatigue failure and has a larger implant-to-bone contact area compared to stainless steel wires thereby reducing the risk of bone cut through. Placement of the cable ties are done similar to wire cerclage thereby not affecting time for sternal closure and training.

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage would improve bone healing, patient function, and decrease postoperative pain.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient age ≥ 18 years
Scheduled cardiac surgery including coronary artery bypass grafting, aortic valve replacement, mitral valve replacement/repair, or ascending aorta replacement.
Patient undergoing elective or urgent surgery
Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion criteria

Patients undergoing emergent cardiac surgery
Severe congestive heart failure (NYHA class III or IV) at enrollment
Prior cardiac surgery
Patients undergoing ventricular assist device insertion or heart transplantation
Patients with a known metal allergy or allergy to ZIPFIX implant
Patients who refuses consent
Patients who are unable to follow post-operative instructions
Prior history of significant bleeding that might be expected to recur with cardiac surgery
Dementia with a mini mental status examination (MMSE) score of < 20
Extra cardiac illness that is expected to limit survival to less than 5 years
Suspected pregnancy. A pregnancy test (urine or serum) will be administered to all women not clearly menopausal
Concurrent enrollment in another clinical trial
Geographic inaccessibility for follow-up visits required by the protocol
Prisoners or institutionalized individuals