Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polymyxin B in Normal Saline | Experimental | Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline |
|
| Placebo: Normal Saline | Placebo Comparator | 0.9 % Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polymyxin B in Normal Saline | Drug | Antibiotic irrigation via peritoneal lavage |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Infections | 30 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Patients With Fistulas | 5 Days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael House, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
more patients enrolled
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo: Normal Saline | 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo: Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Patients With Infections | Posted | Count of Participants | Participants | 30 Days |
|
|
3 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael House | Indiana University School of Medicine | 3179440113 | michouse@iupui.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2014 | Jan 31, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D007239 | Infections |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011112 | Polymyxin B |
| D000077330 | Saline Solution |
| D000900 | Anti-Bacterial Agents |
| ID | Term |
|---|---|
| D011113 | Polymyxins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo: Normal Saline | Other | Placebo irrigation via peritoneal lavage |
|
|
0.9 % Normal Saline
Placebo: Normal Saline: Placebo irrigation via peritoneal lavage
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | The Number of Patients With Fistulas | Posted | Count of Participants | Participants | 5 Days |
|
|
|
| 1 |
| 95 |
| 0 |
| 95 |
| 0 |
| 95 |
| EG001 | Placebo: Normal Saline | 0.9 % Normal Saline Placebo: Normal Saline: Placebo irrigation via peritoneal lavage | 2 | 95 | 0 | 95 | 0 | 95 |
Not provided
Not provided
| D055666 |
| Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |