Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant

Study Overview
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Brief Summary
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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.

Official Title
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Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant

Conditions
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Lung, Lung Transplant

Intervention / Treatment
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* Device: Rigid plate X steel wires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Above 18 years of age; Belonging to the transplant queue of InCor; Eligible for sequential bilateral lung transplantation submitted to clamshell incision; Exclusion Criteria: Patients undergoing a new surgical procedure after lung transplantation with the need to manipulate the steel wires or the sternal fixation plate other than for osteomyelitis; Intraoperative death; Patients who have undergone unilateral lung transplantation or have not undergone a clamshell incision.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SW<br>Patients undergoing sternal closure with steel wires | Device: Rigid plate X steel wires<br>* Compare the sternal alignment between the fixation with rigid plate X steel wires.<br>|
| Experimental: RP<br>Patients undergoing sternal closure with a rigid plate | Device: Rigid plate X steel wires<br>* Compare the sternal alignment between the fixation with rigid plate X steel wires.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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: Significant:> 3mm; Non-significant: ≤3mm Deviation: Grade 1: ≤50% Grade 2:> 50% | 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: Significant:> 3mm; Non-significant: ≤3mm Deviation: Grade 1: ≤50% Grade 2:> 50% | 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: Significant:> 3mm; Non-significant: ≤3mm Deviation: Grade 1: ≤50% Grade 2:> 50% | 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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) (B) Minimal consolidation (sternal separation, lack of bone bridge) (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation) (D) Moderate consolidation (partial bone connection indicating sternal stability) (E) Partial synthesis (significant bone bridge) (F) Complete synthesis (complete bone bridge) | 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) (B) Minimal consolidation (sternal separation, lack of bone bridge) (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation) (D) Moderate consolidation (partial bone connection indicating sternal stability) (E) Partial synthesis (significant bone bridge) (F) Complete synthesis (complete bone bridge) | 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) (B) Minimal consolidation (sternal separation, lack of bone bridge) (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation) (D) Moderate consolidation (partial bone connection indicating sternal stability) (E) Partial synthesis (significant bone bridge) (F) Complete synthesis (complete bone bridge) | 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 |