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| Name | Class |
|---|---|
| Ethicon, Inc. | INDUSTRY |
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Primary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. |
|
| Evicel | Experimental | For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVICEL | Drug | EVICEL |
|
| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B). | First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs | 90 days |
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Inclusion Criteria
Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
Patients must have an ECOG performance status of 0-2
Laboratory values must be within the following ranges:
Patients must sign informed consent for study participation
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Hornig, MD | Medical University of South Carolina | Principal Investigator |
| Shaun A Nguyen, M.D.,CPI | Medical University of South Carolina | Study Director |
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Subjects will be randomized to placebo or Evicel group based on a computer-generated random number sequence.
subjects undergoing total or partial thyroidectomy will be consented for this industry-sponsored prospective randomized placebo-controlled double-blind trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | EVICEL Group | |
| FG001 | Placebo Group |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EVICEL Group | For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply. |
| BG001 | Placebo 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 | To Compare the Amount of Post-operative Wound Drainage Between the Group of Patients in Which EVICEL™ Spray is Utilized (Arm A), and the Group of Patients in Which an EVICEL™ Placebo is Utilized (Arm B). | First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs | Posted | Median | Inter-Quartile Range | mL | 90 days |
|
Time from end of surgery to discharge was recorded for analysis. Adverse events were followed up to six 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 | EVICEL | For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypocalcemia | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shaun A. Nguyen, MD, FAPCR | Medical University of South Carolina - Department of Otolaryngology - Head and Neck Surgery | 8437921356 | nguyensh@musc.edu |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D006042 | Goiter |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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prospective randomized placebo-controlled double-blind trial.
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For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 9 |
| 28 |
| EG001 | Placebo | For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure. | 0 | 27 | 0 | 27 | 3 | 27 |
| hypocalcemia tetany | Endocrine disorders | Systematic Assessment |
|
| TVC paralysis | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Laryngeal edema | Injury, poisoning and procedural complications | Systematic Assessment |
|
| asymptomatic hematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Non-admit ED Incisional and Facial Swelling | Injury, poisoning and procedural complications | Systematic Assessment |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |