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NCT05581017 Clinical Trial

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

Surgical Site Infection Clinical Trial

Official title:
Association of Cephalosporin Resistance in Intraoperative Biliary Cultures With Surgical Site Infections in Patients Undergoing Pancreaticoduodenectomy - A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05581017
Other study ID # HUS-115-2020-56
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 16, 2020
Est. completion date October 10, 2022

Study information
Verified date October 2022
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 376
Est. completion date October 10, 2022
Est. primary completion date September 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Finland Helsinki Central Hospital Helsinki

Sponsors (1)
Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of surgical site infections 30 days post operatively
Primary Prevalence of cephalosporin resistance in intraoperative biliary cultures At the time of operation
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