LungLungTx-LockNCT05055739
Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
A study testing Rigid plate X steel wires in people with Lung and Lung Transplant, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung, Lung Transplant
- What is being tested?
- Rigid plate X steel wires
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 May 2019to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years of age;
- Belonging to the transplant queue of InCor;
- Eligible for sequential bilateral lung transplantation submitted to clamshell incision;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Coração - HCFMUSP
São Paulo, São Paulo, 05403-900
Flavio P dos Reis, MD, +551126615313 ext. 5313, flavio.polo@hc.fm.usp.br
About this study
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
- Being tested
- Rigid plate X steel wires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rigid plate X steel wiresDevice
Compare the sternal alignment between the fixation with rigid plate X steel wires.
| Study group | Role | What they receive |
|---|---|---|
| SW | Experimental | Patients undergoing sternal closure with steel wires Receives: Device: Rigid plate X steel wires |
| RP | Experimental | Patients undergoing sternal closure with a rigid plate Receives: Device: Rigid plate X steel wires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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%
Measured: 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%
Measured: 6 months
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 6 months
Pain
The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).
Measured: 1 month
Pain
The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).
Measured: 3 months
Pain
The patients' postoperative pain will be assessed according to the Pain Score (Pain Score).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start2 May 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paulo Manuel Pêgo Fernandes, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05055739
- Sponsor's protocol ID
- University of Sao Paulo
- Acronym
- LungTx-Lock
- Status last verified
- Sep 2021
- First submitted
- 26 May 2021
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Sternal Closure With Sternalock® Blue Versus Steel Wire Submitted To Bilateral Anterior Transsternal Thoracotomy (Clamshell) For Bilateral Lung Transplant
- ClinicalTrials.gov ID
- NCT05055739
- Acronym / sponsor ID
- LungTx-Lock / University of Sao Paulo
- Conditions
- Lung, Lung Transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 2 May 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SW | Experimental | Device: Rigid plate X steel wiresPatients undergoing sternal closure with steel wires |
| RP | Experimental | Device: Rigid plate X steel wiresPatients undergoing sternal closure with a rigid plate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years of age;
- Belonging to the transplant queue of InCor;
- Eligible for sequential bilateral lung transplantation submitted to clamshell incision;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rigid plate X steel wiresCompare the sternal alignment between the fixation with rigid plate X steel wires. | Device | RP, SW |
Primary outcome
Sternal Alignment
Time frame: 1 month
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%
Sternal Alignment
Time frame: 3 months
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%
Sternal Alignment
Time frame: 6 months
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%
9 secondary outcomes
Bone healing
Time frame: 1 month
Bone healing
Time frame: 3 months
Bone healing
Time frame: 6 months
Pain
Time frame: 1 month
Pain
Time frame: 3 months
Pain
Time frame: 6 months
Time to close the Rib cage
Time frame: 1 month
Time to close the Rib cage
Time frame: 3 months
Time to close the Rib cage
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rigid plate X steel wires in people with Lung and Lung Transplant, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flávio P dos Reis, MD (+551126615313 ext. 5313, flavio.pola@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sternal Alignment (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2021.