Clinical trial NCT01408745: Sternal Closure With STERNUMFIX in Patients With High Risk
Official title: Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Sternum Wound Infection
Nonunion of Fracture of Sternum
Keywords: medical device
sternal closure
sternotomy
dehiscence
sternal wound healing
randomized trial
steel wire
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2011-08-03
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: within three months
Secondary outcomes:
measure: 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.
timeFrame: within 3 months
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bernau
country: Germany
facility: Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
city: Zürich
country: Switzerland
facility: University Hospital Zürich
Study officials:
affiliation: Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB
name: Roland Hetzer, Prof.
role: PRINCIPAL_INVESTIGATOR
References: