Impact of Antibiotic Prophylaxis Change on Surgical Site Infections After Pancreaticoduodenectomy

NCT07531420 | Completed

• 1 other identifier: 2024PI155
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cefazolin; piperacillin/tazobactam

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection rate within 30 days after pancreaticoduodenectomy

  Day 30

Secondary Outcomes (3)

• 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

Study Arms (2)

Period 1 (2022 - 2023)

Adult patients scheduled for pancreatic surgery receiving cefazolin as antibiotic prophylaxis

Period 2 (2024 - 202()

Adult patients scheduled for pancreatic surgery receiving piperacillin/taazobactam as antibiotic prophylaxis

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

Adult patients undergoing pancreaticoduodenectomy for malignancy with preoperative biliary drainage at Nancy University Hospital between January 2022 and December 2025.

You may qualify if:

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

You may not qualify if:

• decline to participate

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Hospital of Nancy

Nancy, France

Location

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: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 15, 2026
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: January 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Locations

FR (1)