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

Not Applicable

• Conditions: Lung Transplant; Lung
• Interventions: Device: Rigid plate X steel wires

• Registration Number: NCT05055739
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-02
• Study First Submitted: 2021-05-26
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-14
• Last Update Submitted: 2021-09-14
• Study First Posted: 2021-09-24
• Last Update Posted: 2021-09-24
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SW	Rigid plate X steel wires	Patients undergoing sternal closure with steel wires
RP	Rigid plate X steel wires	Patients undergoing sternal closure with a rigid plate

Primary Outcome Measures

Name	Time	Method
Sternal Alignment	6 months	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 Outcome Measures

Name	Time	Method
Bone healing	6 months	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 to close the Rib cage	6 months	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.
Pain	6 months	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).

Trial Locations

Locations (1)

Instituto do Coração - HCFMUSP; 🇧🇷 São Paulo, SP, Brazil