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Completed

NCT Number: NCT07531420

Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreatic Surgery Antibiotic Prophylaxis Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection (SSI) Surgical Site Infection Prevention Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Nancy

Nancy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Surgical Site Infection rate within 30 days after pancreaticoduodenectomy

    Time frame: Day 30

Secondary outcomes

  1. Pancreatic fistula rate within 30 days after pancreaticoduodenectomy

    Time frame: Day 30

  2. Postoperative carbapenem exposure

    Time frame: Day 30

  3. Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam

    Time frame: Day 1

    Proportion of bacteria susceptible to cephalosporins and piperacillin/tazobactam isolated by the bile culture sampled during the pancreatic surgery

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: ICADI

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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