Trials / Completed
CompletedNCT07531420
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 117 (actual)
- Sponsor
- Central Hospital, Nancy, France · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2025-12-31
- Completion
- 2026-01-30
- First posted
- 2026-04-15
- Last updated
- 2026-04-15
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT07531420. Inclusion in this directory is not an endorsement.