NCT02186457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable surgery

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable surgery

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

February 23, 2022

Completed
Last Updated

February 23, 2022

Status Verified

January 1, 2022

Enrollment Period

4.4 years

First QC Date

July 1, 2014

Results QC Date

August 14, 2019

Last Update Submit

January 31, 2022

Conditions

SurgeryInfection

Keywords

PancreatoduodenectomyWhipple

Outcome Measures

Primary Outcomes (1)

  • The Number of Patients With Infections

    30 Days

Secondary Outcomes (1)

  • The Number of Patients With Fistulas

    5 Days

Study Arms (2)

Polymyxin B in Normal Saline

EXPERIMENTAL

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

Drug: Polymyxin B in Normal Saline

Placebo: Normal Saline

PLACEBO COMPARATOR

0.9 % Normal Saline

Other: Placebo: Normal Saline

Interventions

Polymyxin B in Normal SalineDRUG

Antibiotic irrigation via peritoneal lavage

Also known as: Antibiotic
Polymyxin B in Normal Saline
Placebo: Normal SalineOTHER

Placebo irrigation via peritoneal lavage

Also known as: Placebo
Placebo: Normal Saline

Eligibility Criteria

Age18 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age and older;
  • Open pancreatoduodenectomy for any diagnosis

You may not qualify if:

  • Pregnant;
  • Prisoners;
  • Patients undergoing concomitant colectomy;
  • Antibiotic allergy to study medication;
  • Serum creatinine \> 2.0;
  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Polymyxin BSaline SolutionAnti-Bacterial Agents

Intervention Hierarchy (Ancestors)

PolymyxinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsAntimicrobial Cationic PeptidesPeptidesAmino Acids, Peptides, and ProteinsAntimicrobial PeptidesPore Forming Cytotoxic ProteinsMembrane ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAnti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Dr. Michael House
Organization
Indiana University School of Medicine
michouse@iupui.edu
3179440113

Study Officials

  • Michael House, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Surgery

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 10, 2014

Study Start

November 1, 2014

Primary Completion

April 1, 2019

Study Completion

August 1, 2019

Last Updated

February 23, 2022

Results First Posted

February 23, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)