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

Primary Purpose

Sternum Wound Infection, Nonunion of Fracture of Sternum

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sternumfix
steel wire
Sponsored by
Aesculap AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sternum Wound Infection focused on measuring medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kerckhoff Klinik
  • Deutsches Herzzentrum Berlin
  • Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
  • University Hospital Zürich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sternumfix

Steel wire

Arm Description

sternotomy closure with Sternumfix

sternotomy closure with steel wire

Outcomes

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

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.

Full Information

First Posted
July 19, 2011
Last Updated
April 13, 2015
Sponsor
Aesculap AG
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1. Study Identification

Unique Protocol Identification Number
NCT01408745
Brief Title
Sternal Closure With STERNUMFIX in Patients With High Risk
Acronym
STEPHIX
Official Title
Multicenter Controlled Study on the Safety and Efficacy of Sternal Closure With STERNUMFIX in Patients With High Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
terminatedd due to insufficient recruitment
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sternum Wound Infection, Nonunion of Fracture of Sternum
Keywords
medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
166 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sternumfix
Arm Type
Experimental
Arm Description
sternotomy closure with Sternumfix
Arm Title
Steel wire
Arm Type
Active Comparator
Arm Description
sternotomy closure with steel wire
Intervention Type
Device
Intervention Name(s)
Sternumfix
Intervention Description
sternotomy closure with Sternumfix
Intervention Type
Procedure
Intervention Name(s)
steel wire
Intervention Description
sternotomy closure with steel wire
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roland Hetzer, Prof.
Organizational Affiliation
Direktor der Klinik für Herz-, Thorax- und Gefäßchirurgie des DHZB
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
ZIP/Postal Code
31231
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Evangelisch-Freikirchliches Krankenhaus und Herzzentrum Brandenburg in Bernau
City
Bernau
ZIP/Postal Code
16321
Country
Germany
Facility Name
University Hospital Zürich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

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Sternal Closure With STERNUMFIX in Patients With High Risk

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