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The purpose of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo.
In this study, the medication (an antibiotic which is used to treat or prevent infections) will be compared with a placebo. A placebo is something that looks like a "real" medication, but it doesn't contain any active medication. As a participant in this study, you may receive the active medication (Cefazolin Sodium Injection or Clindamycin) or you may receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancef 1 gm or Clindamycin 300 mg | Active Comparator | Group A will receive Ancef 1gm or Clindamycin 300mg if penicillin or bet-lactam allergy exists |
|
| Placebo | Placebo Comparator | Group B will receive .9% Normal Saline as a placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ancef or Clindamycin | Drug | 1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic |
|
| Measure | Description | Time Frame |
|---|---|---|
| efficacy of prophylactic antibiotics in reduction of empyema | The primary objective of this study is to examine the efficacy of prophylactic antibiotics in patients with chest tubes for management of thoracic injuries in the reduction of the incidence of empyema as compared to placebo. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Pneumonia and/or development of resistant microorganisms | Secondary objectives include: Incidence of pneumonia Incidence of development of resistant microorganisms | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathaniel McQuay, MD | St. Luke's Hospital and Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Hospital and Health Network | Bethlehem | Pennsylvania | 18015 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 6, 2012 | |
| Reset | Jul 9, 2012 | |
| Release | Apr 30, 2014 | |
| Unrelease | Yes |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 6, 2012 | Jul 9, 2012 | |||
| Apr 30, 2014 |
| ID | Term |
|---|---|
| D006468 | Hemopneumothorax |
| D011030 | Pneumothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
| D006491 | Hemothorax |
| D006470 | Hemorrhage |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Placebo | Drug | .9% Normal Saline as a placebo |
|
| Yes |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |
| D002241 | Carbohydrates |