SternotomyNCT04743895
Study Comparing Steel Wire to a Flat, Braided Suture to Close the Breastbone
A study testing Stainless Steel Wire Cerclage in people with Sternotomy, run by Arthrex, Inc. at 1 site in United States.
Trial summary
This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sternotomy
- What is being tested?
- Stainless Steel Wire Cerclage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2021to 6 May 2022
- 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
- The subject is age 18 or over.
- The subject has a planned full median sternotomy.
- The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.
Who cannot join
- The subject is having a re-operative sternotomy.
- The subject is having an emergency or salvage operation.
- The subject has an unplanned sternotomy incision.
- The subject had an incomplete sternotomy.
- The subject has chronic pain syndromes or chronic narcotic administration.
- The subject has a history of chest irradiation.
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- The subject is unwilling to comply with study follow-up visits and surveys.
- The subject has a sternal infection or suspected sternal infection.
- The subject has any known comorbidity that will influence the outcomes.
- The subject is considered vulnerable (i.e. prisoner, child, pregnant, handicapped, or mentally disabled person).
Trial locations and contacts
1 site in 1 country.
United States1 site
Lee Memorial Health System
Fort Myers, Florida, 33908
About this study
Official title: Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage
This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.
Read the detailed description
The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis).
All adverse events related to the sternal closure procedure or the devices used for closure will be collected.
Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).
- Conditions
- Sternotomy
- Being tested
- Stainless Steel Wire Cerclage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stainless Steel Wire CerclageDevice
Wire cerclage used to close sternum after cardiothoracic surgery.
| Study group | Role | What they receive |
|---|---|---|
| Stainless Steel Wire Cerclage | Active comparator | Sternotomy closure using Stainless Steel Wire Cerclage Receives: Device: Stainless Steel Wire Cerclage |
| FiberTape Cerclage | Active comparator | Sternotomy closure using FiberTape Receives: Device: Stainless Steel Wire Cerclage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of sternal healing
A CT scan will be used to assess sternal healing. Axial slices will be analyzed at 5 locations along the sternum using a 6 point quantitative scale. (0-no healing, 1- minimal healing, 2-mild healing, 3-moderate healing, 4-partial synthesis, 5-complete synthesis).
Measured: 3 months post-operative
Secondary outcomes (4)
Complication rate
Device related adverse event collection
Measured: Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months
Visual Analog Scale (VAS)
Patient reported pain scale using a 10 cm scale with a numeric rating of 0 to 10, with 0 being no pain to 10 being worst pain.
Measured: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Veteran's Rand Health Survey
Patient reported physical and mental health survey. Answers are summarized into 2 scores, a physical component score (PCS) and a mental component score (MCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. The United States population standard deviation is 10 points. Therefore, each increment of 10 points above or below 50 corresponds to one standard deviation away from the population average.
Measured: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Analgesic medication Log
Analgesic use for sternal pain will be collected on a medication log, tracking type of pain medication, dose and start and ends dates.
Measured: Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start4 Jan 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SternotomyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Single Blinded Study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743895
- Sponsor's protocol ID
- US-19092
- Status last verified
- Jun 2022
- First submitted
- 2 Feb 2021
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single Blinded Pilot Study of Stainless Steel Wire Cerclage Versus FiberTape® Cerclage
- ClinicalTrials.gov ID
- NCT04743895
- Acronym / sponsor ID
- US-19092
- Conditions
- Sternotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 8 Feb 2021 (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.
This pilot study is prospective, randomized, single-blinded, single-center for adult patients undergoing sternotomy closure after cardiac surgery. The clinical, patient-reported, and imaging outcomes will be measured comparing standard stainless steel wire (SSW) cerclage versus the FiberTape cerclage.
Detailed description
The primary objective of this study is to evaluate the progression of sternal healing in subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
The secondary objectives are to evaluate the complication rate and postoperative pain of subjects that underwent midline sternal closure with FiberTape cerclage compared to subjects that underwent midline sternal closure with stainless steel wire.
CT scans are performed at three months postoperatively to assess sternal healing. Two radiologists will read all CT scans. Axial slices are analyzed at five locations along the sternum (manubrium, top of the aortic arch, aortopulmonary window, main pulmonary arteries, and aortic root) using a 6-point quantitative scale (0=no sign of healing, 1=minimal healing, 2=mild healing, 3=moderate healing, 4=partial synthesis, 5=complete synthesis).
All adverse events related to the sternal closure procedure or the devices used for closure will be collected.
Postoperative pain scores will be collected using a 10 cm visual analog scale (VAS) with a numeric rating of 0 to 10. Sternal pain will be rated at rest, coughing, and with movement. Postoperative analgesic use for sternal closure pain will be evaluated.The Veterans Rand (VR-12) health survey will be collected postoperatively (see schedule of events for details).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Single Blinded Study
| Arm | Type | Receives |
|---|---|---|
| Stainless Steel Wire Cerclage | Active comparator | Device: Stainless Steel Wire CerclageSternotomy closure using Stainless Steel Wire Cerclage |
| FiberTape Cerclage | Active comparator | Device: Stainless Steel Wire CerclageSternotomy closure using FiberTape |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject is age 18 or over.
- The subject has a planned full median sternotomy.
- The subject has the ability to read, understand and sign the written informed consent document and complete the online surveys.
Key exclusion criteria (10 listed)
- The subject is having a re-operative sternotomy.
- The subject is having an emergency or salvage operation.
- The subject has an unplanned sternotomy incision.
- The subject had an incomplete sternotomy.
- The subject has chronic pain syndromes or chronic narcotic administration.
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 |
|---|---|---|
| Stainless Steel Wire CerclageWire cerclage used to close sternum after cardiothoracic surgery. | Device | FiberTape Cerclage, Stainless Steel Wire Cerclage |
Primary outcome
Progression of sternal healing
Time frame: 3 months post-operative
A CT scan will be used to assess sternal healing. Axial slices will be analyzed at 5 locations along the sternum using a 6 point quantitative scale. (0-no healing, 1- minimal healing, 2-mild healing, 3-moderate healing, 4-partial synthesis, 5-complete synthesis).
4 secondary outcomes
Complication rate
Time frame: Collected at Immediate post-operatively, again at 3 weeks, 6 weeks, 3 months, 6 months
Visual Analog Scale (VAS)
Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Veteran's Rand Health Survey
Time frame: Immediate post-operatively, 3 weeks, 6 weeks, 3 months, 6 months
Analgesic medication Log
Time frame: Collected at immediate post-operatively during hospital stay, again at 3 weeks, 6 weeks, 3 months and 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2022.
- Individual participant dataSharing planned: No
Related trials for Sternotomy
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Superficial Parasternal Block Combined With Rectus Sheath Block for Open Cardiac Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stainless Steel Wire Cerclage in people with Sternotomy, run by Arthrex, Inc. at 1 site in United States.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 21 Jun 2022. 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 United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progression of sternal healing (time frame: 3 months post-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jun 2022.