Association of Cephalosporin Resistance and Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy

Completed

• Conditions: Pancreaticoduodenectomy; Biliary Tract Infection Bacterial; Surgical Site Infection

• Registration Number: NCT05581017
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Preoperative biliary drainage predisposes the bile to be contaminated with bacteria of the duodenum. These bacteria colonizing the bile are a potential source for surgical site infections after pancreaticoduodenectomy and many international guidelines recommend the use of cephalosporines as microbial prophylaxis before surgery. The aim of this study was to assess the incidence of bacteria in bile, their resistance profiles and association to surgical site infections in relation to timing of surgery after preoperative biliary drainage in order to better guide antibiotic use.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-16
• Primary Completion: 2022-09-10
• Status Verified: 2022-10
• Study Completion: 2022-10-10
• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

• All patients undergoing pancreaticoduodenectomy between May 23rd 2016 to October 29th 2020

Exclusion Criteria

• Patients without intraoperative biliary culture
• Patients with unknown date of preoperative biliary culture

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of cephalosporin resistance in intraoperative biliary cultures	At the time of operation
Rate of surgical site infections	30 days post operatively

Trial Locations

Locations (1)

Helsinki Central Hospital; 🇫🇮 Helsinki, Finland