CClinicalTrials.gg
Sign In
TerminatedNCT01408745STEPHIXUpdated Apr 14, 2015

Sternal Closure With STERNUMFIX in Patients With High Risk

A Phase 4 interventional study of Sternumfix and steel wire in Sternum Wound Infection and Nonunion of Fracture of Sternum, sponsored by Aesculap AG. Terminated at 4 sites in 2 countries. Per ClinicalTrials.gov, last updated 2015-04-14.

Sponsored by Aesculap AG · Phase 4, Interventional, and Treatment

Why this study was terminated
terminatedd due to insufficient recruitment
Phase
Phase 4
Study type
Interventional
Enrollment
166
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Sternum Wound Infection
  • Nonunion of Fracture of Sternum

Keywords

  • medical device
  • sternal closure
  • sternotomy
  • dehiscence
  • sternal wound healing
  • randomized trial
  • steel wire
03

In context

Wound Infection

382 studies on the registry are indexed under Wound Infection; 40 are open to participants now.

This study's enrollment of 166 is above the median of 150 across 296 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Aesculap AG is the lead sponsor of 104 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion:

  • Active infection
  • Participation in a pharmaceutical clinical study or any trial with interfering endpoints within the last 30 days
  • Pregnancy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
166 participants (actual)

Study arms

  • Experimental
    Sternumfix

    sternotomy closure with Sternumfix

    Device: Sternumfix

  • Active comparator
    Steel wire

    sternotomy closure with steel wire

    Procedure: steel wire

Interventions

  • DeviceSternumfix

    sternotomy closure with Sternumfix

  • Proceduresteel wire

    sternotomy closure with steel wire

06

What researchers measure

Primary outcomes

  1. 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

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.

    Time frame: within 3 months

07

Study locations

4 sites
  • Kerckhoff Klinik
    Bad Nauheim, 31231, Germany
  • Deutsches Herzzentrum Berlin
    Berlin, 13353, Germany
  • Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
    Bernau, 16321, Germany
  • University Hospital Zürich
    Zürich, 8091, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01408745
Lead sponsor
Aesculap AG
Responsible party
Sponsor
First posted
Aug 3, 2011
Start date
Jun 2008
Primary completion
Aug 2012
Completion
Nov 2012
Last update
Apr 14, 2015

Study contacts

Roland Hetzer, Prof.
principal investigator · Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Wound Infection→

Other studies from this sponsor

Aesculap AG

Start the discussion