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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No CoSeal Surgical Spray | No Intervention | A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. | |
| CoSeal Spray Group | Experimental | CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoSeal Surgical Spray Group | Device | A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Severity of Adhesions at the Retrosternal Site | Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
| Severity of Adhesions at the Arterial Base Site. | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
| Severity of Adhesions at the Diaphragm Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
| Severity of Adhesions at the Left Lateral Site |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Stay | Number of days post surgery. | Length of stay after second surgery up to 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nahidh Hasaniya, MD | Loma Linda University Medical Center | Principal Investigator |
| Anees Razzouk, MD | Loma Linda University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Medical Center | Loma Linda | California | 92602 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | No CoSeal Surgical Spray | A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. |
| FG001 | CoSeal Spray Group | CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No CoSeal Surgical Spray | A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. |
| BG001 | CoSeal Spray Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Severity of Adhesions at the Retrosternal Site | Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Posted | Number | percentage of participants | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
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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 | No CoSeal Surgical Spray | A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest unrelated to device | Congenital, familial and genetic disorders | Non-systematic Assessment | Cardiac Arrest related to complex congenital heart disease which has a 10% mortality rate. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Loma Linda University, Dept of Cardiovascular and Thoracic Surgery | 909-558-4355 | vayermiller@llu.edu |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D000267 | Tissue Adhesions |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).
| Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
| Severity of Adhesions at the Right Lateral Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
| Post-operative Bleeding | Post-operative bleeding through surgical site drainage output. | Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery |
| Adhesion Burden | Skin to bypass time as an indicator of adhesion burden. | Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes) |
CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.
CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
The dose regimen is as follows:
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | CoSeal Spray Group | CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows:
|
|
|
| Primary | Severity of Adhesions at the Arterial Base Site. | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Posted | Number | percentage of participants | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
|
|
|
| Primary | Severity of Adhesions at the Diaphragm Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Posted | Number | percentage of participants | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
|
|
|
| Primary | Severity of Adhesions at the Left Lateral Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Posted | Number | percentage of participants | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
|
|
|
| Primary | Severity of Adhesions at the Right Lateral Site | Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites). | Posted | Number | percentage of participants | Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery |
|
|
|
| Primary | Post-operative Bleeding | Post-operative bleeding through surgical site drainage output. | The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded. | Posted | Mean | Standard Deviation | cm^3 | Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery |
|
|
|
| Primary | Adhesion Burden | Skin to bypass time as an indicator of adhesion burden. | Posted | Mean | Standard Deviation | minutes | Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes) |
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| Secondary | Hospital Stay | Number of days post surgery. | The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated. | Posted | Mean | Standard Deviation | days | Length of stay after second surgery up to 1 month |
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|
| 1 |
| 16 |
| 0 |
| 16 |
| EG001 | CoSeal Spray Group | CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group. CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure. The dose regimen is as follows:
| 3 | 19 | 0 | 19 |
|
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| requiring blunt dissection |
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| requiring sharp dissection |
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| requiring extensive sharp dissection |
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| requiring blunt dissection |
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| requiring sharp dissection |
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| requiring extensive sharp dissection |
|
| requiring blunt dissection |
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| requiring sharp dissection |
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| requiring extensive sharp dissection |
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| requiring blunt dissection |
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| requiring sharp dissection |
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| requiring extensive sharp dissection |
|