TerminatedPhase 4

Sternal Closure With STERNUMFIX in Patients With High Risk

Stopped: terminatedd due to insufficient recruitment

Germany, Switzerland166 participantsStarted 2008-06

Plain-language 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. The control group will be treated with wire cerclage, the standard method of sternal closure.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion: * 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: * 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 Exclusion: * Active infection * Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days * Pregnancy

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: within three months

Trial details

NCT IDNCT01408745

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

View on ClinicalTrials.gov More Sternum Wound Infection trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.