Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy

Impact of Antibiotic Prophylaxis Modification on Surgical Site Infections Following Pancreaticoduodenectomy: The Role of Local Microbiological Ecology (ICADI Study)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07531420

Acronym

ICADI

Enrollment

117

Registered

2026-04-15

Start date

2022-01-01

Completion date

2026-01-30

Last updated

2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Prophylaxis, Pancreatic Surgery, Surgical Site Infection Prevention, Surgical Site Infection (SSI)

Keywords

cefazolin, piperacillin/tazobactam

Brief summary

Patients undergoing pancreaticoduodenectomy after preoperative biliary drainage are at increased risk of surgical site infections (SSI) due to bile colonization. Recent guidelines recommend the use of piperacillin/tazobactam instead of cephalosporins for antibiotic prophylaxis in this population. However, the relevance of this strategy may depend on local microbiological ecology. This monocentric ambispective cohort study aims to compare SSI rates between two periods: before and after implementation of piperacillin/tazobactam prophylaxis. The study also evaluates microbiological profiles of bile cultures, antibiotic susceptibility, and postoperative antibiotic exposure. The primary hypothesis is that adaptation of antibiotic prophylaxis to local ecology may optimize outcomes while limiting unnecessary exposure to broad-spectrum antibiotics.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients (\> 18 yrs) * Scheduled for pancreatic surgery * Presence of preoperative biliary stent * Postoperative admission to surgical ICU or intermediate care unit

Exclusion criteria

* decline to participate

Design outcomes

Primary

Measure	Time frame
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy	Day 30

Secondary

Measure	Time frame	Description
Pancreatic fistula rate within 30 days after pancreaticoduodenectomy	Day 30	—
Postoperative carbapenem exposure	Day 30	—
Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam	Day 1	Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam isolated by the bile culture sampled during the pancreatic surgery

Countries

France

Outcome results