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| Name | Class |
|---|---|
| Surgical Infection Society | UNKNOWN |
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The purpose of this study is to compare the effectiveness of 2 prophylactic antibiotic regimens, ertapenem and cefazolin with metronidazole, in preventing organ space surgical site infections (OS-SSI) after emergency trauma laparotomy embedded into routine clinical care and to validate a Bayesian OS-SSI risk calculator using Trauma Quality Improvement Program (TQIP) standardized variables
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ertapenem only | Experimental |
| |
| Combination of cefazolin and metronidazole. | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ertapenem | Drug | Participants will receive a single dose of IV ertapenem (1g) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that have post-laparotomy OS-SSIs | 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that have superficial incisional SSIs | 30 days after surgery | |
| Number of participants that have deep incisional SSIs | 30 days after surgery | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lillian S Kao, MD | Contact | (713) 500-6280 | Lillian.S.Kao@uth.tmc.edu | |
| Erin E Fox, PhD | Contact | 713 500 7965 | erin.e.fox@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Lillian S Kao, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077727 | Ertapenem |
| D002437 | Cefazolin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Cefazolin and Metronidazole. | Drug | Participants will receive a single dose of a combination of IV cefazolin (re-dosed during the case every 4 hours and/or after every 1,500 mL of blood loss) and IV metronidazole (single dose 500 mg) in the operating room prior to incision or as soon as possible given the patient's hemodynamic status |
|
| Number of patients that show highest Clavien-Dindo grade for OS-SSIs |
grades range from I (minor, requiring no intervention) to V (death) |
| 30 days after surgery |
| Number of unplanned reoperations | 30 days after surgery |
| Number of readmissions | 30 days after surgery |
| Number of participants that have Clostridium difficile infections | 30 days after surgery |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002511 | Cephalosporins |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |