Chronic Obstructive Pulmonary Disease
Conditions
Interventions
The rigid sternal fixation plate (Sternalock® Blu) will be used in 20 patients and steel wires in another 20 patients (control group) for sternal fixation after transverse sternotomy.
Device
E04.555.300
A02.835.232.570.750
Sponsors
Incor (Instituto do Coração)/ FMUSP (Faculdade de Medicina da Universidade de São Paulo)
Incor (Instituto do Coração)/ FMUSP (Faculdade de Medicina da Universidade de São Paulo)
Eligibility
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Above 18 years old; Belonging to the InCor transplant queue; Eligible for sequential bilateral lung transplantation submitted to clamshell incision.
Exclusion criteria
Exclusion criteria: Patients undergoing a new surgical procedure after lung transplantation requiring manipulation of the steel wires or sternal fixation plate other than for osteomyelitis; Intraoperative death; Patients who underwent unilateral lung transplantation or who did not undergo clamshell incision.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Verify the superiority in alignment, measured by the degree of deviation in the sternum cross-section on chest tomography (> or < 50%), from the sternal fixation with rigid plate after clamshell incision over the steel wire fixation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relationship between sternal fixation with rigid plate after clamshell incision in relation to the fixation with steel wire about pain, measured by visual pain scale.;Relationship between sternal fixation with rigid plate after clamshell incision in relation to the fixation with consolidation, assessed by the degree of consolidation in the sternal cross-section on chest tomography (degrees of consolidation from 0 to 5).;Relationship between sternal fixation with rigid plate after clamshell incision in relation to the fixation with steel wire about sternal infection, assessed through clinic and imaging exams if necessary. | — |
Countries
Brazil
Contacts
Public ContactHerbert Costa
Instituto do Coração/Faculdade de Medicina do Estado de São Paulo
Outcome results
None listed