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

Lung Transplant Clinical Trial

— LungTx-Lock  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05055739
• Other study ID #: University of Sao Paulo
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2019
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2021
• Source: University of Sao Paulo General Hospital
• Contact: Flávio P dos Reis, MD
• Phone: +551126615313
• Email: flavio.pola[@]hc.fm.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung
• Lung Transplant

Intervention

Device:
• Rigid plate X steel wires
Compare the sternal alignment between the fixation with rigid plate X steel wires.

Locations

Country	Name	City	State
Brazil	Instituto do Coração - HCFMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	1 month
Secondary	Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	3 months
Secondary	Pain	The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).	6 months
Secondary	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
Secondary	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
Secondary	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