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| Name | Class |
|---|---|
| Instituto de Investigación Biomédica de Salamanca | OTHER |
| Baxter Healthcare Corporation | INDUSTRY |
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The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. |
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| Control group | Other | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopatch | Device |
| ||
| standard preventive measures |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Prolonged Air Leak (PAL) | Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery | From day of surgery to the fifth postoperative day |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Air Leaks | Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators) | Check everyday from day of surgery up to 38 days post-operative at maximum |
| Number of Participants With at Least One Chest Tube Reinsertion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gonzalo Varela, MD PhD FETCS | IBSAL-Instituto de Investigación Biomédica de Salamanca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Marqués de Valdecilla de Santander | Santander | Cantabria | 39008 | Spain | ||
| Hospital Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental Group | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. Hemopatch standard preventive measures |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 17, 2017 |
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Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative. |
| From day of surgery up to 30 days thereafter |
| Number of Participants With One or More Readmission | Rate of readmissions due to relapsing pneumothorax (follow-up 30 days) | 30 days post-operative |
| Barcelona |
| 08036 |
| Spain |
| Hospital Universitario Ramón y Cajal de Madrid | Madrid | 28034 | Spain |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario de Salamanca (CAUSA) | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen del RocÃo | Seville | 41013 | Spain |
| FG001 | Control Group | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat standard preventive measures |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental Group | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. Hemopatch standard preventive measures |
| BG001 | Control Group | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat standard preventive measures |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
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| American Society of Anesthesiologists (ASA) classification | ASA 2: A moderate but definite systemic disturbance. ASA 3: Severe systemic disturbance from any cause or causes. It is not possible to state an absolute measure of severity, as this is a matter of clinical judgment. ASA 4: Extreme systemic disorders which have already become an eminent threat to life regardless of the type of treatment. Because of their duration or nature there has already been damage to the organism that is irreversible. This class is intended to include only patients that are in an extremely poor physical state. | Count of Participants | Participants |
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| Type of Surgery | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Prolonged Air Leak (PAL) | Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery | Posted | Count of Participants | Participants | From day of surgery to the fifth postoperative day |
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| Secondary | Duration of Air Leaks | Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators) | Posted | Mean | Full Range | days | Check everyday from day of surgery up to 38 days post-operative at maximum |
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| Secondary | Number of Participants With at Least One Chest Tube Reinsertion | Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative. | Posted | Count of Participants | Participants | From day of surgery up to 30 days thereafter |
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| Secondary | Number of Participants With One or More Readmission | Rate of readmissions due to relapsing pneumothorax (follow-up 30 days) | Posted | Count of Participants | Participants | 30 days post-operative |
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Through study completion, a total of up to 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental Group | Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis. Hemopatch standard preventive measures | 0 | 118 | 3 | 118 | 0 | 118 |
| EG001 | Control Group | Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat standard preventive measures | 2 | 118 | 7 | 118 | 0 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary. Mechanical ventilation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Reoperation for bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
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Only the population in which a very high rate of PAL is expected was enrolled. There was no stratification by lung function or type of lung resection.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marcelo Jiménez | Hospital Universitario de Salamanca | 923291100 | mfjl@usal.es |
| Apr 15, 2021 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2015 | Apr 15, 2021 | ICF_001.pdf |
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