Antibiotic Irrigation for Pancreatoduodenectomy

Surgery Clinical Trial

Official title:

Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186457
• Other study ID #: 1403644165
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: August 2019

Study information

• Verified date: January 2022
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: August 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections
• Surgery

Intervention

Drug:
• Polymyxin B in Normal Saline
Antibiotic irrigation via peritoneal lavage

Other:
• Placebo: Normal Saline
Placebo irrigation via peritoneal lavage

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Patients With Infections		30 Days
Secondary	The Number of Patients With Fistulas		5 Days