N/A
N=190
Antibiotic Irrigation for Pancreatoduodenectomy
Surgery · Infection
Bottom Line
View on ClinicalTrials.gov: NCT02186457 ↗Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcome: Primary: The Number of Patients With Infections — 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Polymyxin B in Normal Saline (Drug); Placebo: Normal Saline (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients With Infections |
11; 10 | — |
| SECONDARY The Number of Patients With Fistulas |
25; 29 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02186457). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.