Sternal InjuryClosureNCT03289104
Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
A study testing Steel Wires and ZipFix Sternal Closure System in people with Sternal Injury and Cardiac Surgery, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternal Injury, Cardiac Surgery, Heart Diseases
- What is being tested?
- Steel Wires and ZipFix Sternal Closure System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2018to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Sternal Injury, Cardiac Surgery, Heart Diseases
- Being tested
- Steel Wires, ZipFix Sternal Closure System
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steel WiresDevice
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.
ZipFix Sternal Closure SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Steel Wires | Active comparator | In this arm, patients will have their sternum closed with steel wires. Receives: Device: Steel Wires |
| ZipFix Sternal Closure System (Plastic Cables) | Experimental | In this arm, patients will have their sternum closed with the ZipFix system. Receives: Device: ZipFix Sternal Closure System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sternal bone healing
Assessment of how the sternum is healing, assessed via a CT scan and classified using a 6-point scale.
Measured: 3 months after surgery
Secondary outcomes (5)
Post-operative pain
A patient's subjective assessment of their pain after surgery.
Measured: Within 1 week of surgery
Use of narcotics
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.
Measured: In the first 6 months after surgery
Sternal instability
Clinical assessment of patient's sternum stability after surgery
Measured: In the first 6 months after surgery
Sternal wound infection
The presence of sternal wound infection after surgery, confirmed by wound cultures
Measured: In the first 6 months after surgery
Cost
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.
Measured: In the first 6 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2017
- Study startSep 2018 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Why it stopped: Study terminated due to inadequate funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Sternal InjuryStudies of the same condition, open and under way.
- More trials run by Ottawa Heart Institute Research CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Ruel MD MPH FRCSC, Ottawa Heart Institute Research Corporation
- Investigators
- Marc Ruel, MD, MPH, Principal investigator, Ottawa Heart Institute Research Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289104
- Sponsor's protocol ID
- 20160921
- Acronym
- Closure
- Status last verified
- Dec 2018
- First submitted
- 31 Jan 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karamlou T, Jacobs ML, Pasquali S, He X, Hill K, O'Brien S, McMullan DM, Jacobs JP. Surgeon and center volume influence on outcomes after arterial switch operation: analysis of the STS Congenital Heart Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):904-11. doi: 10.1016/j.athoracsur.2014.04.093. Epub 2014 Jul 25.
PubMed 25069686Kozower BD, Sheng S, O'Brien SM, Liptay MJ, Lau CL, Jones DR, Shahian DM, Wright CD. STS database risk models: predictors of mortality and major morbidity for lung cancer resection. Ann Thorac Surg. 2010 Sep;90(3):875-81; discussion 881-3. doi: 10.1016/j.athoracsur.2010.03.115.
PubMed 20732512Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
PubMed 17670585Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8. doi: 10.1016/j.athoracsur.2005.03.089.
PubMed 16122464Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.
PubMed 17888985Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
PubMed 14726062Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
PubMed 15296898Grapow MT, Melly LF, Eckstein FS, Reuthebuch OT. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation. J Cardiothorac Surg. 2012 Jun 25;7:59. doi: 10.1186/1749-8090-7-59.
PubMed 22731778Melly L, Gahl B, Meinke R, Rueter F, Matt P, Reuthebuch O, Eckstein FS, Grapow MT. A new cable-tie-based sternal closure device: infectious considerations. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):219-23; discussion 223-4. doi: 10.1093/icvts/ivt183. Epub 2013 Apr 26.
PubMed 23624983Stelly MM, Rodning CB, Stelly TC. Reduction in deep sternal wound infection with use of a peristernal cable-tie closure system: a retrospective case series. J Cardiothorac Surg. 2015 Nov 14;10:166. doi: 10.1186/s13019-015-0378-7.
PubMed 26577944
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX
- ClinicalTrials.gov ID
- NCT03289104
- Acronym / sponsor ID
- Closure / 20160921
- Conditions
- Sternal Injury, Cardiac Surgery, Heart Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study terminated due to inadequate funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 20 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steel Wires | Active comparator | Device: Steel WiresIn this arm, patients will have their sternum closed with steel wires. |
| ZipFix Sternal Closure System (Plastic Cables) | Experimental | Device: ZipFix Sternal Closure SystemIn this arm, patients will have their sternum closed with the ZipFix system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steel WiresControl: 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. | Device | Steel Wires |
| ZipFix Sternal Closure SystemTreatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery. | Device | ZipFix Sternal Closure System (Plastic Cables) |
Primary outcome
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.
5 secondary outcomes
Post-operative pain
Time frame: Within 1 week of surgery
Use of narcotics
Time frame: In the first 6 months after surgery
Sternal instability
Time frame: In the first 6 months after surgery
Sternal wound infection
Time frame: In the first 6 months after surgery
Cost
Time frame: In the first 6 months after surgery.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Background: PubMed 25069686Karamlou T, Jacobs ML, Pasquali S, He X, Hill K, O'Brien S, McMullan DM, Jacobs JP. Surgeon and center volume influence on outcomes after arterial switch operation: analysis of the STS Congenital Heart Surgery Database. Ann Thorac Surg. 2014 Sep;98(3):904-11. doi: 10.1016/j.athoracsur.2014.04.093. Epub 2014 Jul 25.
- Background: PubMed 20732512Kozower BD, Sheng S, O'Brien SM, Liptay MJ, Lau CL, Jones DR, Shahian DM, Wright CD. STS database risk models: predictors of mortality and major morbidity for lung cancer resection. Ann Thorac Surg. 2010 Sep;90(3):875-81; discussion 881-3. doi: 10.1016/j.athoracsur.2010.03.115.
- Background: PubMed 17670585Raman J, Song DH, Bolotin G, Jeevanandam V. Sternal closure with titanium plate fixation--a paradigm shift in preventing mediastinitis. Interact Cardiovasc Thorac Surg. 2006 Aug;5(4):336-9. doi: 10.1510/icvts.2005.121863. Epub 2006 Apr 25.
- Background: PubMed 16122464Pai S, Gunja NJ, Dupak EL, McMahon NL, Roth TP, Lalikos JF, Dunn RM, Francalancia N, Pins GD, Billiar KL. In vitro comparison of wire and plate fixation for midline sternotomies. Ann Thorac Surg. 2005 Sep;80(3):962-8. doi: 10.1016/j.athoracsur.2005.03.089.
- Background: PubMed 17888985Losanoff JE, Basson MD, Gruber SA, Huff H, Hsieh FH. Single wire versus double wire loops for median sternotomy closure: experimental biomechanical study using a human cadaveric model. Ann Thorac Surg. 2007 Oct;84(4):1288-93. doi: 10.1016/j.athoracsur.2007.05.023.
- Background: PubMed 14726062Losanoff JE, Collier AD, Wagner-Mann CC, Richman BW, Huff H, Hsieh Fh, Diaz-Arias A, Jones JW. Biomechanical comparison of median sternotomy closures. Ann Thorac Surg. 2004 Jan;77(1):203-9. doi: 10.1016/s0003-4975(03)01468-1.
- Background: PubMed 15296898Song DH, Lohman RF, Renucci JD, Jeevanandam V, Raman J. Primary sternal plating in high-risk patients prevents mediastinitis. Eur J Cardiothorac Surg. 2004 Aug;26(2):367-72. doi: 10.1016/j.ejcts.2004.04.038.
- Background: PubMed 22731778Grapow MT, Melly LF, Eckstein FS, Reuthebuch OT. A new cable-tie based sternal closure system: description of the device, technique of implantation and first clinical evaluation. J Cardiothorac Surg. 2012 Jun 25;7:59. doi: 10.1186/1749-8090-7-59.
- Background: PubMed 23624983Melly L, Gahl B, Meinke R, Rueter F, Matt P, Reuthebuch O, Eckstein FS, Grapow MT. A new cable-tie-based sternal closure device: infectious considerations. Interact Cardiovasc Thorac Surg. 2013 Aug;17(2):219-23; discussion 223-4. doi: 10.1093/icvts/ivt183. Epub 2013 Apr 26.
- Background: PubMed 26577944Stelly MM, Rodning CB, Stelly TC. Reduction in deep sternal wound infection with use of a peristernal cable-tie closure system: a retrospective case series. J Cardiothorac Surg. 2015 Nov 14;10:166. doi: 10.1186/s13019-015-0378-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ruel, MD, MPH principal investigator
Ottawa Heart Institute Research Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steel Wires and ZipFix Sternal Closure System in people with Sternal Injury and Cardiac Surgery, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal bone healing (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03289104, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.