Surgical Site InfectionBIOSTEPSNCT04199494
Antibiotic Stewardship Program in Pancreatic Surgery: a Multicenter Time Series Analysis (BIOSTEPS).
An observational study of Surgical Site Infection and Antibiotic Resistant Infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in Italy.
Trial summary
Rationale: Surgical site infection (SSI) is one of the most frequently reported postoperative complication, occurring in up to one-third of patients. Its development causes a substantial increase in the clinical and economic burden of pancreatic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infection, Antibiotic Resistant Infection
- What is being tested?
- Antibiotic Stewardship Program
- How many people
- 1,200 participants
- Where
- 2 sitesItaly
- Study dates
- 16 Dec 2019to 16 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the Rectal Swab culture, two weeks before surgery.
Who may be able to join
- Scheduled for elective pancreatic resection
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) score < 4
- The ability of the subject to understand the character and individual consequences of the clinical trial
- Written informed consent
Who cannot join
- Under 18 years of age
- ASA score ≥4
- Immune suppressed patients
- Pregnant women
- Participation in another study with interference of study outcomes
- Impaired mental state or language problems
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
AOUI Verona
Verona, 37124
Matteo De Pastena, MD, 0039 0458126254, m.depastena@gmail.com
Giovanni Marchegiani, MD, 0039 0458126254, giovanni.marchegiani@aovr.veneto.it
- Recruiting
AOUI Verona
Verona, 37124
Erica Secchettin, +390458126254, erica.secchettin@aovr.veneto.it
Claudio Bassi, Prof
About this study
Rationale: Surgical site infection (SSI) is one of the most frequently reported postoperative complication, occurring in up to one-third of patients. Its development causes a substantial increase in the clinical and economic burden of pancreatic surgery. Nowadays, the primary goal of a surgical department is the reduction of the SSI rate, based on a cautious approach to the prescription of the antibiotic prophylaxis (AP) to avoid the spread of multi-drug resistant (MDR) bacteria. An antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis could be an optimal strategy to reduce the impact of infectious complications after pancreatic surgery. However, few data are available regarding this topic.
Objective: To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI and the inappropriate use of key antibiotics in patients undergoing pancreatic surgery.
Read more
Study design: A time series study will be conducted. The antimicrobial stewardship program is shared between three national high-volume centers of pancreatic surgery. Statistical significance and effect size were calculated by segmented regression analysis of interrupted time series of drug use, SSI rate, and costs for 3 years before and after the introduction of the program.
Study population: Patients with an indication for elective pancreatic surgery.
Main study parameters/endpoints: Primary outcome is the reduction of SSI rate. Secondary outcomes are the reduction of the use of the key antibiotics (such as piperacillin/tazobactam and carbapenems), the microbial whole-genome sequencing (WGS) of the carbapenemase-producing Enterobacteriaceae, and the reduction of the treatment costs
Read the detailed description
A multicenter time series with segmented regression analysis will be conducted at three national high-volume centers of pancreatic surgery: The General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome. All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the RS culture, two weeks before surgery. All patients enrolled will receive a preoperative clinical visit two weeks before surgery. During the patient's interview, the surgeon will collect the medical history, exposing the clinical and surgical perioperative pathways. The patient is also submitted to the routinely preoperative lab tests, including the RS. The study design is based on evidence collected by previous studies of the group and after a systematic review of the literature. The ASP has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics.
- Being tested
- Antibiotic Stewardship Program
- 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.
Antibiotic Stewardship ProgramOther
The patient do the routinely preoperative lab tests, including the rectal swab (RS). The Antibiotic Stewardship Program (ASP) has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics
What is being measured
The primary outcome is the main question the study is designed to answer.
SSI rate after pancreatic surgery
To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI until 30th day after surgery in patients undergoing pancreatic surgery
Measured: 30th day after surgery
Secondary outcomes (3)
Antibiotic Stewardship Program in Pancreatic Surgery
To evaluate the useful of an antibiotic stewardship program in the change of the inappropriate use of key antibiotics, such as piperacillin/tazobactam and carbapenems, in administered for prophylaxis or treatment of the SSI
Measured: 30th day after surgery
Whole genome sequencing of MDR bacteria
To analyze the genotype of the carbapenemase-producing Enterobacteriaceae performing the microbial WGS
Measured: 30th day after surgery
Treatment costs
To evaluate the useful of an antibiotic stewardship program in the change of the treatment costs
Measured: 30th day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2019
- Study start16 Dec 2019
- Primary completion1 Sep 2022 (estimated)
- Study completion16 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04199494
- Sponsor's protocol ID
- TRS 2018-00001695
- Acronym
- BIOSTEPS
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Pastena M, Paiella S, Lionetto G, Casciani F, Sereni E, Pea A, Malleo G, Salvia R. An Antimicrobial Stewardship Program in Pancreatic Surgery Reduces the Infectious Risk of Colonized Bile, Reducing the Predictive Value of the Intraoperative Bile Culture: A Before-after Study on 1638 Pancreatoduodenectomies. Ann Surg. 2025 Nov 1;282(5):725-733. doi: 10.1097/SLA.0000000000006870. Epub 2025 Aug 1.
PubMed 40747933
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Stewardship Program in Pancreatic Surgery: a Multicenter Time Series Analysis (BIOSTEPS).
- ClinicalTrials.gov ID
- NCT04199494
- Acronym / sponsor ID
- BIOSTEPS / TRS 2018-00001695
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Agenzia Italiana del Farmaco
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 16 Dec 2022 (estimated)
- First posted
- 16 Dec 2019 (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.
Rationale: Surgical site infection (SSI) is one of the most frequently reported postoperative complication, occurring in up to one-third of patients. Its development causes a substantial increase in the clinical and economic burden of pancreatic surgery. Nowadays, the primary goal of a surgical department is the reduction of the SSI rate, based on a cautious approach to the prescription of the antibiotic prophylaxis (AP) to avoid the spread of multi-drug resistant (MDR) bacteria. An antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis could be an optimal strategy to reduce the impact of infectious complications after pancreatic surgery. However, few data are available regarding this topic.
Objective: To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI and the inappropriate use of key antibiotics in patients undergoing pancreatic surgery.
Study design: A time series study will be conducted. The antimicrobial stewardship program is shared between three national high-volume centers of pancreatic surgery. Statistical significance and effect size were calculated by segmented regression analysis of interrupted time series of drug use, SSI rate, and costs for 3 years before and after the introduction of the program.
Study population: Patients with an indication for elective pancreatic surgery.
Main study parameters/endpoints: Primary outcome is the reduction of SSI rate. Secondary outcomes are the reduction of the use of the key antibiotics (such as piperacillin/tazobactam and carbapenems), the microbial whole-genome sequencing (WGS) of the carbapenemase-producing Enterobacteriaceae, and the reduction of the treatment costs
Detailed description
A multicenter time series with segmented regression analysis will be conducted at three national high-volume centers of pancreatic surgery: The General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome. All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the RS culture, two weeks before surgery. All patients enrolled will receive a preoperative clinical visit two weeks before surgery. During the patient's interview, the surgeon will collect the medical history, exposing the clinical and surgical perioperative pathways. The patient is also submitted to the routinely preoperative lab tests, including the RS. The study design is based on evidence collected by previous studies of the group and after a systematic review of the literature. The ASP has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients visited at the General and Pancreatic Surgery Department, Pancreas Institute, of Verona, the Oncological and Robotic General Surgery, Careggi Hospital, University of Florence, and the Department of Surgery, University Campus Bio-Medico of Rome and scheduled for pancreatic resection will be enrolled. The patients will be submitted to the routinely diagnostic preoperative procedures, including the Rectal Swab culture, two weeks before surgery.
Key inclusion criteria (5 listed)
- Scheduled for elective pancreatic resection
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) score < 4
- The ability of the subject to understand the character and individual consequences of the clinical trial
- Written informed consent
Key exclusion criteria (6 listed)
- Under 18 years of age
- ASA score ≥4
- Immune suppressed patients
- Pregnant women
- Participation in another study with interference of study outcomes
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 |
|---|---|---|
| Antibiotic Stewardship ProgramThe patient do the routinely preoperative lab tests, including the rectal swab (RS). The Antibiotic Stewardship Program (ASP) has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics | Other | – |
Primary outcome
SSI rate after pancreatic surgery
Time frame: 30th day after surgery
To evaluate the useful of an antimicrobial stewardship program and a patient-tailored antibiotic prophylaxis in the reduction of the occurrence of SSI until 30th day after surgery in patients undergoing pancreatic surgery
3 secondary outcomes
Antibiotic Stewardship Program in Pancreatic Surgery
Time frame: 30th day after surgery
Whole genome sequencing of MDR bacteria
Time frame: 30th day after surgery
Treatment costs
Time frame: 30th day after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Derived from this study: PubMed 40747933De Pastena M, Paiella S, Lionetto G, Casciani F, Sereni E, Pea A, Malleo G, Salvia R. An Antimicrobial Stewardship Program in Pancreatic Surgery Reduces the Infectious Risk of Colonized Bile, Reducing the Predictive Value of the Intraoperative Bile Culture: A Before-after Study on 1638 Pancreatoduodenectomies. Ann Surg. 2025 Nov 1;282(5):725-733. doi: 10.1097/SLA.0000000000006870. Epub 2025 Aug 1.
- 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.
2 sites 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 Antibiotic Resistant Infection, run by Azienda Ospedaliera Universitaria Integrata Verona at 2 sites in Italy.
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 5 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: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SSI rate after pancreatic surgery (time frame: 30th day after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04199494, which also lists 1 linked publication.
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 19 Feb 2020.