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

NCT05055739 | Unknown

• 1 other identifier: University of Sao Paulo
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung; Lung Transplant

Outcome Measures

Primary Outcomes (3)

• 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%

  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%

  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%

  6 months

Secondary Outcomes (9)

• Bone healing

  1 month

• Bone healing

  3 months

• Bone healing

  6 months

• Pain

  1 month

• Pain

  3 months

Study Arms (2)

SW

EXPERIMENTAL

Patients undergoing sternal closure with steel wires

Device: Rigid plate X steel wires

RP

EXPERIMENTAL

Patients undergoing sternal closure with a rigid plate

Device: Rigid plate X steel wires

Interventions

Rigid plate X steel wires DEVICE

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

RP; SW

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above 18 years of age;
• Belonging to the transplant queue of InCor;
• Eligible for sequential bilateral lung transplantation submitted to clamshell incision;

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

Central Study Contacts

Flávio P dos Reis, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: September 24, 2021
• Study Start: May 2, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 24, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)