Lung, Lung Transplant
Conditions
Brief summary
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.
Interventions
DEVICERigid plate X steel wires
Compare the sternal alignment between the fixation with rigid plate X steel wires.
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Above 18 years of age; 2. Belonging to the transplant queue of InCor; 3. Eligible for sequential bilateral lung transplantation submitted to clamshell incision;
Exclusion criteria
1. 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; 2. Intraoperative death; 3. Patients who have undergone unilateral lung transplantation or have not undergone a clamshell incision.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sternal Alignment | 1 month | 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: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone healing | 1 month | 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) 1. (B) Minimal consolidation (sternal separation, lack of bone bridge) 2. (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation) 3. (D) Moderate consolidation (partial bone connection indicating sternal stability) 4. (E) Partial synthesis (significant bone bridge) 5. (F) Complete synthesis (complete bone bridge) |
| Pain | 1 month | The patients' postoperative pain will be assessed according to the Pain Score (Pain Score). |
| Time to close the Rib cage | 1 month | 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. |
Countries
Brazil
Contacts
Primary ContactFlávio P dos Reis, MD
Outcome results
None listed