Antibiotic Irrigation for Pancreatoduodenectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2019-08-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Surgery Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Polymyxin B in Normal Saline

Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline

Group Type EXPERIMENTAL

Polymyxin B in Normal Saline

Intervention Type DRUG

Antibiotic irrigation via peritoneal lavage

Placebo: Normal Saline

0.9 % Normal Saline

Group Type PLACEBO_COMPARATOR

Placebo: Normal Saline

Intervention Type OTHER

Placebo irrigation via peritoneal lavage

Interventions

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Polymyxin B in Normal Saline

Antibiotic irrigation via peritoneal lavage

Intervention Type DRUG

Placebo: Normal Saline

Placebo irrigation via peritoneal lavage

Intervention Type OTHER

Other Intervention Names

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Antibiotic Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No