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

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 Overview

• Status: Recruiting
• Conditions: Lung; Lung Transplant
• Intervention / Treatment: Device: Rigid plate X steel wires

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Flávio P dos Reis, MD; Phone Number: 5313 +551126615313; Email: flavio.pola@hc.fm.usp.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 05403-900
      • Recruiting
      • Instituto do Coracao - HCFMUSP
      • Contact: Flavio P dos Reis, MD; Phone Number: 5313 +551126615313; Email: flavio.polo@hc.fm.usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SW; Patients undergoing sternal closure with steel wires	Device: Rigid plate X steel wires; Compare the sternal alignment between the fixation with rigid plate X steel wires.
Experimental: RP; Patients undergoing sternal closure with a rigid plate	Device: Rigid plate X steel wires; Compare the sternal alignment between the fixation with rigid plate X steel wires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Significant:> 3mm;; Non-significant: ≤3mm Deviation: Grade 1: ≤50%; 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: Significant:> 3mm;; Non-significant: ≤3mm Deviation: Grade 1: ≤50%; 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: Significant:> 3mm;; Non-significant: ≤3mm Deviation: Grade 1: ≤50%; Grade 2:> 50%	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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); (B) Minimal consolidation (sternal separation, lack of bone bridge); (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation); (D) Moderate consolidation (partial bone connection indicating sternal stability); (E) Partial synthesis (significant bone bridge); (F) Complete synthesis (complete bone bridge)	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); (B) Minimal consolidation (sternal separation, lack of bone bridge); (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation); (D) Moderate consolidation (partial bone connection indicating sternal stability); (E) Partial synthesis (significant bone bridge); (F) Complete synthesis (complete bone bridge)	3 months
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); (B) Minimal consolidation (sternal separation, lack of bone bridge); (C) Median consolidation (sternal separation with some trace of bone bridge, immature bone formation); (D) Moderate consolidation (partial bone connection indicating sternal stability); (E) Partial synthesis (significant bone bridge); (F) Complete synthesis (complete bone bridge)	6 months
Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	1 month
Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	3 months
Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	6 months
Time to close the Rib cage	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.	1 month
Time to close the Rib cage	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.	3 months
Time to close the Rib cage	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.	6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: University of Sao Paulo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No