Antibiotic Irrigation for Pancreatoduodenectomy

Indiana University190 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

190

Conditions

Surgery Infection

Interventions

Polymyxin B in Normal SalineDRUG

Antibiotic irrigation via peritoneal lavage

Placebo: Normal SalineOTHER

Placebo irrigation via peritoneal lavage

Eligibility

Sex: ALLMin age: 18 YearsMax age: 88 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

The Number of Patients With Infections

Time frame: 30 Days

Secondary Outcomes

The Number of Patients With Fistulas

Time frame: 5 Days

Data from ClinicalTrials.gov

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