Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

Status Withdrawn

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03289104
Study type	Interventional
Source	Ottawa Heart Institute Research Corporation
Contact
Status	Withdrawn
Phase	N/A
Start date	September 2018
Completion date	September 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX — Closure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms