Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX (Closure)
|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.|
|ClinicalTrials.gov Identifier: NCT03289104|
Recruitment Status : Withdrawn (Study terminated due to inadequate funding.)
First Posted : September 20, 2017
Last Update Posted : December 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sternal Injury Cardiac Surgery Heart Diseases||Device: Steel Wires Device: ZipFix Sternal Closure System||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Active Comparator: Steel Wires
In this arm, patients will have their sternum closed with steel wires.
Device: Steel Wires
Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.
Experimental: ZipFix Sternal Closure System (Plastic Cables)
In this arm, patients will have their sternum closed with the ZipFix system.
Device: ZipFix Sternal Closure System
Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.
- Sternal bone healing [ Time Frame: 3 months after surgery ]Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.
- Post-operative pain [ Time Frame: Within 1 week of surgery ]A patient's subjective assessment of their pain after surgery.
- Use of narcotics [ Time Frame: In the first 6 months after surgery ]A patient's use of narcotic pain medication. To assess this measure, the proportion of patients in each group using narcotic pain medication will be compared.
- Sternal instability [ Time Frame: In the first 6 months after surgery ]Clinical assessment of patient's sternum stability after surgery
- Sternal wound infection [ Time Frame: In the first 6 months after surgery ]The presence of sternal wound infection after surgery, confirmed by wound cultures
- Cost [ Time Frame: In the first 6 months after surgery. ]An approximation of the comparative cost of the ZipFix system versus sternal wires, which will be approximated by comparing the duration of hospital stay between groups; the use of narcotic pain medication between groups; and the rate of sternal wound infection between groups.
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 ClinicalTrials.gov identifier (NCT number): NCT03289104
|Division of Cardiac Surgery|
|Ottawa, Ontario, Canada, K1Y4W7|
|Principal Investigator:||Marc Ruel, MD, MPH||Ottawa Heart Institute Research Corporation|