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

NCT05581017 | Completed

• 1 other identifier: HUS-115-2020-56
• Study Type: observational
• Target: 376
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection; Pancreaticoduodenectomy; Biliary Tract Infection Bacterial

Outcome Measures

Primary Outcomes (2)

• Rate of surgical site infections

  30 days post operatively

• Prevalence of cephalosporin resistance in intraoperative biliary cultures

  At the time of operation

Study Arms (3)

No PBD

Patients without preoperative biliary drainage before pancreaticoduodenectomy

PBD < 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was in 2 months after the drainage.

Procedure: Preoperative biliary drainage

PBD ≥ 2 months

Patients who had undergone preoperative biliary drainage and the pancreaticoduodenectomy was at 2 months or later after the drainage.

Procedure: Preoperative biliary drainage

Interventions

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.

PBD < 2 months; PBD ≥ 2 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients undergoing pancreaticoduodenectomy in a single high volume center between May 23rd 2016 to October 29th 2020.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki Central Hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Timo O Tarvainen, MD

  Gastroenterological Surgery, Helsinki University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 14, 2022
• Study Start: June 16, 2020
• Primary Completion: September 10, 2022
• Study Completion: October 10, 2022
• Last Updated: March 12, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)