Impact of Antibiotic Prophylaxis Modification on Surgical Site Infections Following Pancreaticoduodenectomy: The Role of Local Microbiological Ecology (ICADI Study)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Central Hospital, Nancy, France
- Enrollment
- 117
- Locations
- 1
- Primary Endpoint
- Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Outcomes
Primary Outcomes
Surgical Site Infection rate within 30 days after pancreaticoduodenectomy
Time Frame: Day 30
Secondary Outcomes
- 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)