SurgeryNCT02186457
Antibiotic Irrigation for Pancreatoduodenectomy
A study testing Polymyxin B in Normal Saline in people with Surgery and Infection, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- What is being tested?
- Polymyxin B in Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Aug 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 88 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age and older;
- Open pancreatoduodenectomy for any diagnosis
Who cannot join
- Pregnant;
- Prisoners;
- Patients undergoing concomitant colectomy;
- Antibiotic allergy to study medication;
- Serum creatinine > 2.0;
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates
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.
Read the 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.
- Being tested
- Polymyxin B in Normal Saline, Placebo: Normal Saline
- Keywords
- Pancreatoduodenectomy, Whipple
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymyxin B in Normal SalineDrug
Also called Antibiotic
Antibiotic irrigation via peritoneal lavage
Placebo: Normal SalineOther
Also called Placebo
Placebo irrigation via peritoneal lavage
| Study group | Role | What they receive |
|---|---|---|
| Polymyxin B in Normal Saline | Experimental | Polymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline Receives: Drug: Polymyxin B in Normal Saline |
| Placebo: Normal Saline | Placebo comparator | 0.9 % Normal Saline Receives: Other: Placebo: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Patients With Infections
Measured: 30 Days
Secondary outcomes (1)
The Number of Patients With Fistulas
Measured: 5 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael G. House, Indiana University
- Investigators
- Michael House, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186457
- Sponsor's protocol ID
- 1403644165
- Status last verified
- Jan 2022
- First submitted
- 1 Jul 2014
- Last updated
- 23 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Antibiotic Irrigation in Patients Undergoing Pancreatoduodenectomy to Reduce Infection and Fistula Rates
- ClinicalTrials.gov ID
- NCT02186457
- Acronym / sponsor ID
- 1403644165
- Keywords
- Pancreatoduodenectomy, Whipple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Posted 23 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polymyxin B in Normal Saline | Experimental | Drug: Polymyxin B in Normal SalinePolymyxin B (500,000 U) in 1 liter of 0.9% Normal Saline |
| Placebo: Normal Saline | Placebo comparator | Other: Placebo: Normal Saline0.9 % Normal Saline |
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 18 years of age and older;
- Open pancreatoduodenectomy for any diagnosis
Key exclusion criteria (6 listed)
- Pregnant;
- Prisoners;
- Patients undergoing concomitant colectomy;
- Antibiotic allergy to study medication;
- Serum creatinine > 2.0;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymyxin B in Normal SalineAlso: AntibioticAntibiotic irrigation via peritoneal lavage | Drug | Polymyxin B in Normal Saline |
| Placebo: Normal SalineAlso: PlaceboPlacebo irrigation via peritoneal lavage | Other | Placebo: Normal Saline |
Primary outcome
The Number of Patients With Infections
Time frame: 30 Days
1 secondary outcome
The Number of Patients With Fistulas
Time frame: 5 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael House, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polymyxin B in Normal Saline in people with Surgery and Infection, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Patients With Infections (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.