Surgery, Infection
Conditions
Keywords
Pancreatoduodenectomy, Whipple
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.
Interventions
DRUGPolymyxin B in Normal Saline
Antibiotic irrigation via peritoneal lavage
Placebo irrigation via peritoneal lavage
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 88 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Number of Patients With Infections | 30 Days |
Secondary
| Measure | Time frame |
|---|---|
| The Number of Patients With Fistulas | 5 Days |
Countries
United States
Participant flow
Pre-assignment details
more patients enrolled
Participants by arm
| Arm | Count |
|---|---|
| Polymyxin B in Normal Saline Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline
Polymyxin B in Normal Saline: Antibiotic irrigation via peritoneal lavage | 95 |
| Placebo: Normal Saline 0.9 % Normal Saline
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage | 95 |
| Total | 190 |
Baseline characteristics
| Characteristic | Total | Polymyxin B in Normal Saline | Placebo: Normal Saline |
|---|---|---|---|
| Age, Categorical Age distribution <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Age distribution >=65 years | 75 Participants | 35 Participants | 40 Participants |
| Age, Categorical Age distribution Between 18 and 65 years | 115 Participants | 60 Participants | 55 Participants |
| Age, Continuous | 64.1 years STANDARD_DEVIATION 1.4 | 63.7 years STANDARD_DEVIATION 1.3 | 64.4 years STANDARD_DEVIATION 1.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 178 Participants | 90 Participants | 88 Participants |
| Region of Enrollment United States | 190 participants | 95 participants | 95 participants |
| Sex: Female, Male Female | 78 Participants | 40 Participants | 38 Participants |
| Sex: Female, Male Male | 112 Participants | 55 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 95 | 2 / 95 |
| other Total, other adverse events | 0 / 95 | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 | 0 / 95 |
Outcome results
Primary
The Number of Patients With Infections
Time frame: 30 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polymyxin B in Normal Saline | The Number of Patients With Infections | 11 Participants |
| Placebo: Normal Saline | The Number of Patients With Infections | 10 Participants |
Secondary
The Number of Patients With Fistulas
Time frame: 5 Days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Polymyxin B in Normal Saline | The Number of Patients With Fistulas | 25 Participants |
| Placebo: Normal Saline | The Number of Patients With Fistulas | 29 Participants |