Sternum Wound InfectionPhase 4STEPHIXNCT01408745
Sternal Closure With STERNUMFIX in Patients With High Risk
A Phase 4 study testing Sternumfix and steel wire in people with Sternum Wound Infection and Nonunion of Fracture of Sternum, run by Aesculap AG at 4 sites in 2 countries.
Trial summary
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sternum Wound Infection, Nonunion of Fracture of Sternum
- What is being tested?
- Sternumfix and steel wire
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jun 2008to Nov 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing elective cardiac surgery with a median sternotomy
- Age >18 years
- Male and female sex
- Informed consent
- Patients with high risk for sternal wound complications
- Patients are designated as high risk patients if they have either:
Show all 22Show fewer
- one or more major risk factors or
- four or more minor risk factors.
- Major risk factors are:
- Obesity: BMI > 30.
- Diabetes: intake of oral anti-diabetic drugs and/or insulin at time of surgery.
- COPD: history of chronic coughing plus expectoration for at least 3 months by at least two consecutive years, plus evidence of restrictive pattern at spirometry.
- Planned BITA: bilateral use of thoracic artery
- Age > 75 years
- Minor risk factors are:
- History of smoking;(minimum of 1 year of history of smoking)
- Hyperlipoproteinaemia (as stated in the patient data)
- Planned surgery is a CABG
- Patient is on dialysis
- Repeat sternotomy
- Left ventricular ejection fraction < 30% (as stated in the patient data)
- Male sex
Who cannot join
- Active infection
- Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days
- Pregnancy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Kerckhoff Klinik
Bad Nauheim, 31231
Deutsches Herzzentrum Berlin
Berlin, 13353
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau, 16321
About this study
Official title: Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk
The primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. The control group will be treated with wire cerclage, the standard method of sternal closure.
- Being tested
- Sternumfix, steel wire
- Keywords
- medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SternumfixDevice
sternotomy closure with Sternumfix
steel wireProcedure or surgery
sternotomy closure with steel wire
| Study group | Role | What they receive |
|---|---|---|
| Sternumfix | Experimental | sternotomy closure with Sternumfix Receives: Device: Sternumfix |
| Steel wire | Active comparator | sternotomy closure with steel wire Receives: Procedure: steel wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population
Measured: within three months
Secondary outcomes (1)
Adverse event rate. Postoperative chest pain. Length of postoperative hospital stay. Blood loss within the first 12 hours p.o. Duration of the sternal fixation.
Measured: within 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startJun 2008
- Primary completionAug 2012
- Study completionNov 2012
Why it stopped: terminatedd due to insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sternum Wound InfectionStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roland Hetzer, Prof., Principal investigator, Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408745
- Sponsor's protocol ID
- AAG-G-H-0802
- Acronym
- STEPHIX
- Status last verified
- Apr 2015
- First submitted
- 19 Jul 2011
- Last updated
- 14 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk
- ClinicalTrials.gov ID
- NCT01408745
- Acronym / sponsor ID
- STEPHIX / AAG-G-H-0802
- Keywords
- medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminatedd due to insufficient recruitment
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- 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 primary objective is to establish if the SternumFix System improves sternal closure. The study should test the hypothesis that in a high risk patient population with increased risk for the development of sternal wound complications SternumFix will reduce the incidence of sternal healing complications. The control group will be treated with wire cerclage, the standard method of sternal closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sternumfix | Experimental | Device: Sternumfixsternotomy closure with Sternumfix |
| Steel wire | Active comparator | Procedure: steel wiresternotomy closure with steel wire |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (22 listed)
- Patients undergoing elective cardiac surgery with a median sternotomy
- Age >18 years
- Male and female sex
- Informed consent
- Patients with high risk for sternal wound complications
Key exclusion criteria (3 listed)
- Active infection
- Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days
- Pregnancy
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 |
|---|---|---|
| Sternumfixsternotomy closure with Sternumfix | Device | Sternumfix |
| steel wiresternotomy closure with steel wire | Procedure or surgery | Steel wire |
Primary outcome
cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population
Time frame: within three months
1 secondary outcome
Adverse event rate. Postoperative chest pain. Length of postoperative hospital stay. Blood loss within the first 12 hours p.o. Duration of the sternal fixation.
Time frame: within 3 months
Results and safety
The study was stopped early (reason given: terminatedd due to insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2015.
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.
Roland Hetzer, Prof. principal investigator
Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sternumfix and steel wire in people with Sternum Wound Infection and Nonunion of Fracture of Sternum, run by Aesculap AG at 4 sites in 2 countries.
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 22 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminatedd due to insufficient recruitment). Results are not available in the source record.
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?
cumulative three-months incidence of re-operation rates due to sternal instability or infection for patients with SternumFix in comparison to sternal fixation with wires in a high risk patient population (time frame: within three months). 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 14 Apr 2015.