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

April 13, 2015 updated by: Aesculap AG

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

166

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
within three months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
within 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Investigators

  • Principal Investigator: Roland Hetzer, Prof., Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (ESTIMATE)

August 3, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 14, 2015

Last Update Submitted That Met QC Criteria

April 13, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-0802

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sternum Wound Infection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe