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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Lung Transplant; Lung

Treatments: Device: Rigid plate X steel wires

Study type: Interventional

Funder types: Other

Identifiers

NCT05055739

University of Sao Paulo

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

SW

Experimental group

Description:

Patients undergoing sternal closure with steel wires

Treatment:

Device: Rigid plate X steel wires

RP

Experimental group

Description:

Patients undergoing sternal closure with a rigid plate

Treatment:

Device: Rigid plate X steel wires