Antibiotic Irrigation for Pancreatoduodenectomy

• Sponsor: Indiana University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02186457
• Collaborator: (none)
• Enrollment: 190
• Location: 1
• Arms: 2
• Actual Duration (Months): 57
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgery; Infection	Drug: Polymyxin B in Normal Saline; Other: Placebo: Normal Saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 190 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Polymyxin B in Normal Saline Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline	Drug: Polymyxin B in Normal Saline; Antibiotic irrigation via peritoneal lavage; Other Names: Antibiotic
Placebo Comparator: Placebo: Normal Saline 0.9 % Normal Saline	Other: Placebo: Normal Saline; Placebo irrigation via peritoneal lavage; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. The Number of Patients With Infections [30 Days]

Secondary Outcome Measures

1. The Number of Patients With Fistulas [5 Days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 88 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University

Investigators

• Principal Investigator: Michael House, MD, Indiana University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 31, 2014

More Information

Publications

None provided.

• Responsible Party: Michael G. House, Associate Professor of Surgery, Indiana University
• ClinicalTrials.gov Identifier: NCT02186457
• Other Study ID Numbers: 1403644165
• First Posted: Jul 10, 2014
• Last Update Posted: Feb 23, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michael G. House, Associate Professor of Surgery, Indiana University: Pancreatoduodenectomy; Whipple
• Additional relevant MeSH terms: Infections; Anti-Bacterial Agents; Polymyxins; Polymyxin B

Study Results

Participant Flow

Pre-assignment Detail	more patients enrolled

Arm/Group Title	Polymyxin B in Normal Saline	Placebo: Normal Saline
Arm/Group Description	Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
Period Title: Overall Study
STARTED	95	95
COMPLETED	95	95
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Polymyxin B in Normal Saline	Placebo: Normal Saline	Total
Arm/Group Description	Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage	Total of all reporting groups
Overall Participants	95	95	190
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	60 63.2%	55 57.9%	115 60.5%
>=65 years	35 36.8%	40 42.1%	75 39.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.7 (1.3)	64.4 (1.5)	64.1 (1.4)
Sex: Female, Male (Count of Participants)
Female	40 42.1%	38 40%	78 41.1%
Male	55 57.9%	57 60%	112 58.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.1%	2 2.1%	3 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1.1%	2 2.1%	3 1.6%
White	90 94.7%	88 92.6%	178 93.7%
More than one race	3 3.2%	2 2.1%	5 2.6%
Unknown or Not Reported	0 0%	1 1.1%	1 0.5%
Region of Enrollment (participants) [Number]
United States	95 100%	95 100%	190 100%

Outcome Measures

1. Primary Outcome

Title	The Number of Patients With Infections
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Polymyxin B in Normal Saline	Placebo: Normal Saline
Arm/Group Description	Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
Measure Participants	95	95
Count of Participants [Participants]	11 11.6%	10 10.5%

2. Secondary Outcome

Title	The Number of Patients With Fistulas
Time Frame	5 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Polymyxin B in Normal Saline	Placebo: Normal Saline
Arm/Group Description	Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage	0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
Measure Participants	95	95
Count of Participants [Participants]	25 26.3%	29 30.5%

Adverse Events

Time Frame	3 years
Arm/Group Title	Polymyxin B in Normal Saline		Placebo: Normal Saline
Arm/Group Description	Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage		0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
All Cause Mortality
	Polymyxin B in Normal Saline		Placebo: Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/95 (1.1%)		2/95 (2.1%)
Serious Adverse Events
	Polymyxin B in Normal Saline		Placebo: Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/95 (0%)
Other (Not Including Serious) Adverse Events
	Polymyxin B in Normal Saline		Placebo: Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/95 (0%)		0/95 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.