Nonunion of Fracture of Sternum, Sternum Wound Infection
Conditions
Keywords
medical device, sternal closure, sternotomy, dehiscence, sternal wound healing, randomized trial, steel wire
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.
Interventions
DEVICESternumfix
sternotomy closure with Sternumfix
PROCEDUREsteel wire
sternotomy closure with steel wire
Sponsors
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| 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 | within three months |
Secondary
| 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. | within 3 months |
Countries
Germany, Switzerland
Outcome results
None listed