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Completed

NCT Number: NCT02186457

Antibiotic Irrigation for Pancreatoduodenectomy

The purpose of this study is to determine if the routine use of antibiotic irrigation during pancreas surgery (Whipple procedure) will decrease superficial and organ space infections.

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Key information

Conditions

Surgery Infection Infections

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University

Indianapolis, Indiana, 46202, United States

About this study

The primary aim of this study is to test the efficacy of routine antibiotic irrigation in reducing superficial and organ space infections among patients undergoing pancreatoduodenectomy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age and older;
  • Open pancreatoduodenectomy for any diagnosis

Exclusion criteria

  • Pregnant;
  • Prisoners;
  • Patients undergoing concomitant colectomy;
  • Antibiotic allergy to study medication;
  • Serum creatinine > 2.0;
  • Unable to provide informed consent

Treatment and study plan

Polymyxin B in Normal Saline

Drug

Antibiotic irrigation via peritoneal lavage

Other names: Antibiotic

Placebo: Normal Saline

Other

Placebo irrigation via peritoneal lavage

Other names: Placebo

Primary outcomes

  1. The Number of Patients With Infections

    Time frame: 30 Days

Secondary outcomes

  1. The Number of Patients With Fistulas

    Time frame: 5 Days

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 10, 2014
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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