Antibiotic Irrigation for Pancreatoduodenectomy
Not Applicable
Completed
- Conditions
- InfectionSurgery
- Interventions
- Drug: Polymyxin B in Normal Saline
- Registration Number
- NCT02186457
- Lead Sponsor
- Indiana University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 190
Inclusion Criteria
- At least 18 years of age and older;
- Open pancreatoduodenectomy for any diagnosis
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Exclusion Criteria
- Pregnant;
- Prisoners;
- Patients undergoing concomitant colectomy;
- Antibiotic allergy to study medication;
- Serum creatinine > 2.0;
- Unable to provide informed consent
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polymyxin B in Normal Saline Polymyxin B in Normal Saline Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline
- Primary Outcome Measures
Name Time Method The Number of Patients With Infections 30 Days
- Secondary Outcome Measures
Name Time Method The Number of Patients With Fistulas 5 Days
Trial Locations
- Locations (1)
Indiana University
🇺🇸Indianapolis, Indiana, United States