Antibiotic Stewardship Program in Pancreatic Surgery: a Multicenter Time Series Analysis (BIOSTEPS).

NCT04199494 | Unknown

• 1 other identifier: TRS 2018-00001695
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

Brief 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. 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

Conditions

Surgical Site Infection; Antibiotic Resistant Infection

Outcome Measures

Primary Outcomes (1)

• 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

  30th day after surgery

Secondary Outcomes (3)

• Antibiotic Stewardship Program in Pancreatic Surgery

  30th day after surgery

• Whole genome sequencing of MDR bacteria

  30th day after surgery

• Treatment costs

  30th day after surgery

Interventions

Antibiotic Stewardship Program OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead
• Agenzia Italiana del Farmaco: collaborator

Study Sites (2)

AOUI Verona

Verona, 37124, Italy

RECRUITING

AOUI Verona

Verona, 37124, Italy

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 16, 2019
• Study Start: December 16, 2019
• Primary Completion: September 1, 2022
• Study Completion: December 16, 2022
• Last Updated: February 19, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)