NCT05055739 - Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

40

Conditions

Lung Lung Transplant

Interventions

Rigid plate X steel wiresDEVICE

Compare the sternal alignment between the fixation with rigid plate X steel wires.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, Brazil

RECRUITING

Outcomes

Primary Outcomes

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: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%

Time frame: 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: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%

Time frame: 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: 1. Significant:\> 3mm; 2. Non-significant: ≤3mm Deviation: 1. Grade 1: ≤50% 2. Grade 2:\> 50%

Time frame: 6 months

Secondary Outcomes

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) 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)

Time frame: 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) 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)

Central Contacts

Flávio P dos Reis, MD

CONTACT

+551126615313 flavio.pola@hc.fm.usp.br