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Sternal Closure With STERNUMFIX in Patients With High Risk (STEPHIX)

This study has been terminated.
(terminatedd due to insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01408745
First received: July 19, 2011
Last updated: June 15, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Sternum Wound Infection
Nonunion of Fracture of Sternum
 Device: Sternumfix
Procedure: steel wire
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 166
Study Start Date: June 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sternumfix
sternotomy closure with Sternumfix
 Device: Sternumfix
sternotomy closure with Sternumfix
Active Comparator: Steel wire
sternotomy closure with steel wire
 Procedure: steel wire
sternotomy closure with steel wire

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01408745

Locations
Germany
Kerckhoff Klinik
Bad Nauheim, Germany, 31231
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
Bernau, Germany, 16321
Switzerland
University Hospital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Roland Hetzer, Prof. Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01408745     History of Changes
Other Study ID Numbers: AAG-G-H-0802
Study First Received: July 19, 2011
Last Updated: June 15, 2012
Health Authority: Germany:Regierungspräsidium Freiburg

Keywords provided by Aesculap AG:
medical device
sternal closure
sternotomy
dehiscence
 sternal wound healing
randomized trial
steel wire

Additional relevant MeSH terms:
Fractures, Ununited
Wound Infection
Fractures, Bone
Wounds and Injuries
Infection

ClinicalTrials.gov processed this record on May 19, 2013