Sternal Closure With STERNUMFIX in Patients With High Risk

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Montage-Enhanced Sternal Closure

NCT03365843

Sternal Closure

UNKNOWN PHASE2

Feasibility Study of Aastrom Tissue Repair Cells to Treat Non-Union Fractures.

NCT00424567

Fracture, Ununited Pseudarthrosis

TERMINATED PHASE1/PHASE2

Intracapsular Femoral Neck Fractures Fixation With a Dynamic Locking Plate and Screw System, Targon FN

NCT00830687

Femoral Neck Fractures

UNKNOWN NA

Humeral Compression/Distraction Device

NCT02861495

Humeral Fractures

TERMINATED NA

Union Rate of Transverse Tibia Fracture

NCT03042533

Closed Transverse Fracture of Shaft of Tibia

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sternum Wound Infection Nonunion of Fracture of Sternum

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sternumfix

sternotomy closure with Sternumfix

Group Type EXPERIMENTAL

Sternumfix

Intervention Type DEVICE

sternotomy closure with Sternumfix

Steel wire

sternotomy closure with steel wire

Group Type ACTIVE_COMPARATOR

steel wire

Intervention Type PROCEDURE

sternotomy closure with steel wire

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Sternumfix

sternotomy closure with Sternumfix

Intervention Type DEVICE

steel wire

sternotomy closure with steel wire

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No