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OpenTrials
Completed

NCT Number: NCT05581017

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

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki Central Hospital

Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Preoperative biliary drainage

Procedure

Preoperative biliary drainage before pancreaticoduodenectomy. Might be needed if the biliary tract in obstructed and the surgery cannot be scheduled in near future.

Primary outcomes

  1. Rate of surgical site infections

    Time frame: 30 days post operatively

  2. Prevalence of cephalosporin resistance in intraoperative biliary cultures

    Time frame: At the time of operation

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Registry information

Official study title

Association of Cephalosporin Resistance in Intraoperative Biliary Cultures with Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - a Retrospective Cohort Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 14, 2022
Registry last updated
Mar 12, 2025

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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