Antibiotic Irrigation for Pancreatoduodenectomy

Indiana University

Status: Completed

Conditions: Infection; Surgery

Treatments: Drug: Polymyxin B in Normal Saline; Other: Placebo: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02186457

1403644165

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 190 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

Polymyxin B in Normal Saline

Experimental group

Description:

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

Treatment:

Drug: Polymyxin B in Normal Saline

Placebo: Normal Saline

Placebo Comparator group

Description:

0.9 % Normal Saline

Treatment:

Other: Placebo: Normal Saline