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This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.
Same as above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacitracin | Experimental | Nasopore sponge soaked in Bacitracin, no oral antibiotics |
|
| Saline | No Intervention | Nasopore sponge soaked in saline, routine oral antibiotics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacitracin | Drug | Bacitracin soaked nasopore sponge |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Infection | Number of participants without infections on post-op visits 90 days. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Catalano, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Elizabeth's Medical Center | Brighton | Massachusetts | 02135 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bacitracin | Nasopore sponge soaked in Bacitracin Bacitracin: Bacitracin soaked sponge |
| FG001 | Saline | Saline soaked sponge and oral antibiotics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bacitracin | Nasopore sponge soaked in Bacitracin Bacitracin: Bacitracin soaked sponge |
| BG001 | Saline | Nasopore sponge soaked in saline |
| 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 | Rate of Infection | Number of participants without infections on post-op visits 90 days. | Posted | Count of Participants | Participants | 90 days |
|
|
1 year
on case by case bases
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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 | Bacitracin | Bacitracin soaked sponge | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter catalano | SEMC | 617-789-5004 | peter.catalano@steward.org |
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| ID | Term |
|---|---|
| D010254 | Paranasal Sinus Diseases |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D001414 | Bacitracin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
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| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 113 |
| 0 |
| 113 |
| 0 |
| 113 |
| EG001 | Saline | Saline soaked sponge and oral antibiotics | 0 | 113 | 0 | 113 | 0 | 113 |
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| D000602 |
| Amino Acids, Peptides, and Proteins |