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NCT04199494: BIOSTEPS
Antibiotic Stewardship Program in Pancreatic Surgery: a Multicenter Time Series Analysis (BIOSTEPS).
trial testing Antibiotic Stewardship Program in Surgical Site Infection in 1,200 participants. Status unknown.
1 September 2022
Quick facts
| Lead sponsor | Azienda Ospedaliera Universitaria Integrata Verona |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,200 |
| Start date | 16 December 2019 |
| Primary completion | 1 September 2022 |
| Estimated completion | 16 December 2022 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Antibiotic Stewardship Program
Conditions studied
- Surgical Site Infection — all drugs for Surgical Site Infection →
- Antibiotic Resistant Infection — all drugs for Antibiotic Resistant Infection →
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona — full company profile →
Who can join
18 and older, any sex, with Surgical Site Infection or Antibiotic Resistant Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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.
De Pastena M, Paiella S, Lionetto G, Casciani F, et al · · 2025 · cited 1× · PMID 40747933 · DOI 10.1097/sla.0000000000006870
Verify or expand the search:
- PubMed search for NCT04199494
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Azienda Ospedaliera Universitaria Integrata Verona trials
Trials by the same sponsor.
- NCT07325877 — Supra-papillary Versus Trans-papillary Biliary Stenting in Malignant Peri-hilar Stenosis · NA · not yet recruiting
- NCT07289035 — Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators. · Phase 2 · not yet recruiting
- NCT07186582 — Verona Coronary Physiology Interventional Registry · active not recruiting
- NCT06820541 — Gallbladder Stenting in FC-SEMS · NA · not yet recruiting
- NCT07338708 — Visual Outcomes and Quality of Life After Vivity EDOF IOL Implantation in Early-Stage Keratoconus · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04199494 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Azienda Ospedaliera Universitaria Integrata Verona
- Last refreshed: 19 February 2020
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