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| Name | Class |
|---|---|
| Indiana University | OTHER |
| Massachusetts General Hospital | OTHER |
| Thomas Jefferson University | OTHER |
| Washington University School of Medicine |
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The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefoxitin | Active Comparator |
| |
| Piperacillin-tazobactam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefoxitin | Drug | Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael D'Angelica, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States | ||
| Emory University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37078771 | Derived | D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728. | |
| 33664081 |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cefoxitin | Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| FG001 | Piperacillin-tazobactam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 20, 2019 |
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| OTHER |
| Advocate Illinois Masonic Medical Center | OTHER |
| Baptist Memorial Health Care Corporation | OTHER |
| Baylor Scott and White Health | OTHER |
| The Cleveland Clinic | OTHER |
| Emory University | OTHER |
| Fox Chase Cancer Center | OTHER |
| Gundersen Lutheran Medical Center | UNKNOWN |
| Hackensack Meridian Health | OTHER |
| Hamilton Health Sciences Center | UNKNOWN |
| Intermountain Health Care, Inc. | OTHER |
| Jersey Shore Medical Center (Hackensack Meridian) | UNKNOWN |
| Johns Hopkins University | OTHER |
| Montefiore Medical Center/Albert Einstein College of Medicine | UNKNOWN |
| North Shore University HealthSystem | UNKNOWN |
| Milton S. Hershey Medical Center | OTHER |
| Rhode Island Hospital | OTHER |
| Stony Brook Medicine | UNKNOWN |
| Sunnybrook Health Sciences Centre, Canada | UNKNOWN |
| Temple University | OTHER |
| Ohio State University | OTHER |
| The Ottowa Hospital/University of Ottowa | UNKNOWN |
| University of California, Davis | OTHER |
| University of Chicago | OTHER |
| University of Iowa | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| University of Utah | OTHER |
| University of Wisconsin, Madison | OTHER |
| Providence Health & Services | OTHER |
| Albany Medical College | OTHER |
| Northwestern University | OTHER |
| Universtiy of Mississippi Medical Center | UNKNOWN |
| Mount Sinai Hospital, New York | OTHER |
| Brody School of Medicine at East Carolina University | UNKNOWN |
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| Piperacillin-tazobactam | Drug | Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern Medicine (Data Collection) | Chicago | Illinois | 60611 | United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Washington School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| Memorial Sloan Kettering Basking Ridge (Consent only) | Basking Ridge | New Jersey | 07920 | United States |
| Hackensack Meridian Health / Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Memorial Sloan Kettering Commack (Consent only) | Commack | New York | 11725 | United States |
| Memoral Sloan Kettering Westchester (Consent only) | Harrison | New York | 10604 | United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| Mount Sinai West | New York | New York | 10029 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Montefiore Health Systems (Montefiore Medical Center) | The Bronx | New York | 10467 | United States |
| Duke University | Durham | North Carolina | 27713 | United States |
| Brody School of Medicine at East Carolina University | Greenville | North Carolina | 27834 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Providence Health & Services (Portland Med Ctr) | Portland | Oregon | 97213 | United States |
| Pennsylvania State Hershey | Hershey | Pennsylvania | 17033 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Baptist Memorial Healthcare | Memphis | Tennessee | 38120 | United States |
| Baylor Scott & White Health | Dallas | Texas | 75246 | United States |
| Intermountain Healthcare | Murray | Utah | 84107 | United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| Gundersen Lutheran Medical Foundation | La Crosse | Wisconsin | 54601 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Hamilton Health Sciences Center (Juravinski Hospital) | Hamilton | Ontario | Canada |
| Ottawa Hospital | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Derived |
| Nevarez NM, Brajcich BC, Liu J, Ellis R, Ko CY, Pitt HA, D'Angelica MI, Yopp AC. Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398. |
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cefoxitin | Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| BG001 | Piperacillin-tazobactam | Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
| |||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual. | Posted | Count of Participants | Participants | 30 days |
|
|
|
30 days
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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 | Cefoxitin | Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | 10 | 400 | 10 | 400 | 0 | 400 |
| EG001 | Piperacillin-tazobactam | Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | 5 | 378 | 5 | 378 | 0 | 378 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael D'Angelica, MD | Memorial Sloan Kettering Cancer Center | 212-639-3226 | dangelim@mskcc.org |
| Aug 25, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010182 | Pancreatic Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D002440 | Cefoxitin |
| D000077725 | Piperacillin, Tazobactam Drug Combination |
| ID | Term |
|---|---|
| D002513 | Cephamycins |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D000078142 | Tazobactam |
| D010397 | Penicillanic Acid |
| D010406 | Penicillins |
| D010878 | Piperacillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D013450 | Sulfones |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|