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

NCT ID: NCT05055739

Last Updated: 2021-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-02
• Study Completion Date: 2022-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SW

Patients undergoing sternal closure with steel wires

Group Type: EXPERIMENTAL

Rigid plate X steel wires

Intervention Type: DEVICE

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

RP

Patients undergoing sternal closure with a rigid plate

Group Type: EXPERIMENTAL

Rigid plate X steel wires

Intervention Type: DEVICE

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

Interventions

Rigid plate X steel wires

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paulo Manuel Pêgo Fernandes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Instituto do Coração - HCFMUSP

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Flávio P dos Reis, MD

Role: CONTACT

flavio.pola@hc.fm.usp.br

+551126615313 ext. 5313

Facility Contacts

Flavio P dos Reis, MD

Role: primary

flavio.polo@hc.fm.usp.br

+551126615313 ext. 5313

Other Identifiers

University of Sao Paulo

Identifier Type: -

Identifier Source: org_study_id