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This will be a prospective, randomized clinical trial, comparing the sternal alignment between the fixation with rigid plate X steel wires. Patients over 18 years of age, belonging to the lung transplant line in the State of São Paulo, who will undergo bilateral lung transplantation will be studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SW | Experimental | Patients undergoing sternal closure with steel wires |
|
| RP | Experimental | Patients undergoing sternal closure with a rigid plate |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rigid plate X steel wires | Device | Compare the sternal alignment between the fixation with rigid plate X steel wires. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sternal Alignment | Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment:
Deviation:
| 1 month |
| Sternal Alignment | Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment:
Deviation:
| 3 months |
| Sternal Alignment | Sternal alignment will be analyzed through cross-sections of chest computed tomography by a certified radiologist. Two parameters will be used for sternal alignment: Misalignment:
Deviation:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Bone healing | Bone healing will be analyzed through cross-sections of chest computed tomography by a certified radiologist. • The degree of bone healing will be classified into 6 levels: 0- (A) No signs of consolidation (no clear consolidation, no union, sternal separation)
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Flávio P dos Reis, MD | Contact | +551126615313 | 5313 | flavio.pola@hc.fm.usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração - HCFMUSP | Recruiting | São Paulo | São Paulo | 05403-900 | Brazil |
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| 1 month |
| Bone healing | Bone healing will be analyzed through cross-sections of chest computed tomography by a certified radiologist. • The degree of bone healing will be classified into 6 levels: 0- (A) No signs of consolidation (no clear consolidation, no union, sternal separation)
| 3 months |
| Bone healing | Bone healing will be analyzed through cross-sections of chest computed tomography by a certified radiologist. • The degree of bone healing will be classified into 6 levels: 0- (A) No signs of consolidation (no clear consolidation, no union, sternal separation)
| 6 months |
| Pain | The patients' postoperative pain will be assessed according to the Pain Score (Pain Score). | 1 month |
| Pain | The patients' postoperative pain will be assessed according to the Pain Score (Pain Score). | 3 months |
| Pain | The patients' postoperative pain will be assessed according to the Pain Score (Pain Score). | 6 months |
| Time to close the Rib cage | Time to close the Rib cage will be measured from the insertion of the last chest drain until the total closure of the skin of the thorax. | 1 month |
| Time to close the Rib cage | Time to close the Rib cage will be measured from the insertion of the last chest drain until the total closure of the skin of the thorax. | 3 months |
| Time to close the Rib cage | Time to close the Rib cage will be measured from the insertion of the last chest drain until the total closure of the skin of the thorax. | 6 months |