Surgical Site InfectionNCT05581017
Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy
An observational study of Surgical Site Infection and Pancreaticoduodenectomy, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Surgical Site Infection, Pancreaticoduodenectomy, Biliary Tract Infection Bacterial
- What is being tested?
- Preoperative biliary drainage
- Type of treatment
- Surgery or procedure
- How many people
- 376 participants
- Where
- 1 siteFinland
- Study dates
- 16 Jun 2020to 10 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing pancreaticoduodenectomy in a single high volume center between May 23rd 2016 to October 29th 2020.
Who may be able to join
- All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020
Who cannot join
- Patients without intraoperative biliary culture
- Patients with unknown date of preoperative biliary culture
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Cephalosporin Resistance in Intraoperative Biliary Cultures with Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - a Retrospective Cohort Study
Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.
- Being tested
- Preoperative biliary drainage
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative biliary drainageProcedure or surgery
Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.
| Study group | Role | What they receive |
|---|---|---|
| No PBD | Patients without preoperative biliary drainage before pancreaticoduodenectomy | |
| PBD < 2 months | Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage. Receives: Procedure: Preoperative biliary drainage | |
| PBD ≥ 2 months | Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage. Receives: Procedure: Preoperative biliary drainage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of surgical site infections
Measured: 30 days post operatively
Prevalence of cephalosporin resistance in intraoperative biliary cultures
Measured: At the time of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start16 Jun 2020
- Primary completion10 Sep 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timo Tarvainen, Helsinki University Central Hospital
- Investigators
- Timo O Tarvainen, MD, Principal investigator, Gastroenterological Surgery, Helsinki University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581017
- Sponsor's protocol ID
- HUS-115-2020-56
- Status last verified
- Oct 2022
- First submitted
- 12 Oct 2022
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Cephalosporin Resistance in Intraoperative Biliary Cultures with Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05581017
- Acronym / sponsor ID
- HUS-115-2020-56
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No PBD | – | –Patients without preoperative biliary drainage before pancreaticoduodenectomy |
| PBD < 2 months | – | Procedure: Preoperative biliary drainagePatients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage. |
| PBD ≥ 2 months | – | Procedure: Preoperative biliary drainagePatients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing pancreaticoduodenectomy in a single high volume center between May 23rd 2016 to October 29th 2020.
Key inclusion criteria (1 listed)
- All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020
Key exclusion criteria (2 listed)
- Patients without intraoperative biliary culture
- Patients with unknown date of preoperative biliary culture
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 |
|---|---|---|
| Preoperative biliary drainagePreoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future. | Procedure or surgery | PBD < 2 months, PBD ≥ 2 months |
Primary outcome
Rate of surgical site infections
Time frame: 30 days post operatively
Prevalence of cephalosporin resistance in intraoperative biliary cultures
Time frame: At the time of operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- 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.
Timo O Tarvainen, MD principal investigator
Gastroenterological Surgery, Helsinki University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Site Infection and Pancreaticoduodenectomy, run by Helsinki University Central Hospital at 1 site in Finland.
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 1 inclusion and 2 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 12 Mar 2025. 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 Finland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of surgical site infections (time frame: 30 days post operatively). The study lists 2 primary outcomes in all. 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 12 Mar 2025.