Comparison between sternal closure with sternal plate fixation versus steel wire after transverse sternotomy for bilateral pulmonary transplantatio

Not Applicable

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease; Cystic fibrosis; Pulmonary fibrosis; Pulmonary Hypertension; Bronchiectasis; J44.1; C08.381.495.389; C08.381.483.487.500; C08.381.423; C08.127.384

• Registration Number: RBR-5gdwzz
• Lead Sponsor: Incor (Instituto do Coração)/ FMUSP (Faculdade de Medicina da Universidade de São Paulo)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Above 18 years old; Belonging to the InCor transplant queue; Eligible for sequential bilateral lung transplantation submitted to clamshell incision.

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.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.