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Trial · NCT03269994

Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?

NCT03269994, Phase 3, Completed, Memorial Sloan Kettering Cancer Center; results first posted 2025-10-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy? Trials, record NCT03269994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03269994

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
NCT number
NCT03269994
Status
Completed
Phases
Phase 3
Enrollment
967 participants, actual
Lead sponsor
Memorial Sloan Kettering Cancer Center
Conditions
Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
Interventions
Cefoxitin, Piperacillin-tazobactam
First posted
2017-09-01
Last updated
2025-10-21
Results first posted
2025-10-21

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.30 days
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.

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.30 daysParticipantsCOUNT_OF_PARTICIPANTS

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.Cefoxitin400Participants
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.Piperacillin-tazobactam378Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDCefoxitin484
Overall StudySTARTEDPiperacillin-tazobactam483
Overall StudyCOMPLETEDCefoxitin400
Overall StudyCOMPLETEDPiperacillin-tazobactam378
Overall StudyNOT COMPLETEDCefoxitin84
Overall StudyNOT COMPLETEDPiperacillin-tazobactam105

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
seriousDeathGeneral disordersCefoxitin10400
seriousDeathGeneral disordersPiperacillin-tazobactam5378

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityCefoxitin10400
Total, all-cause mortalityPiperacillin-tazobactam5378
Total, other adverse eventsCefoxitin0400
Total, other adverse eventsPiperacillin-tazobactam0378
Total, serious adverse eventsCefoxitin10400
Total, serious adverse eventsPiperacillin-tazobactam5378

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
33664081DERIVEDPubMed
37078771DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Cefoxitin vs Piperacillin-tazobactam: Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.Trial comparisons
Cefoxitin vs Piperacillin-tazobactam: deaths from any causeTrial comparisons
Cefoxitin vs Piperacillin-tazobactam: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03269994

GET https://conductscience.org/api/trials/v1/NCT03269994/registered