Impact of Alternative Prophylactic Antibiotics on Surgical Site Infections During a Cefazolin Shortage: A Retrospective Cohort Study in Gastrointestinal Surgery

Impact of Alternative Prophylactic Antibiotics on Surgical Site Infections During a Cefazolin Shortage: A Retrospective Cohort Study in Gastrointestinal Surgery - Impact of Alternative Prophylactic Antibiotics During Cefazolin Shortage in Gastrointestinal Surgery

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000058179

Enrollment

3500

Registered

2025-06-15

Start date

2024-01-19

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal surgery

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who met all of the following criteria were included: (1) underwent cholecystectomy, gastrectomy, esophagectomy, or hepatectomy between February 1, 2018, and June 30, 2020; (2) received surgery for which cefazolin was the standard prophylactic antibiotic; (3) were aged 18 years or older.

Exclusion criteria

Exclusion criteria: Patients who met any of the following criteria were excluded from this study: (1) emergency surgery cases; (2) patients with active bacterial infections; (3) patients who were already receiving antibiotics (oral or intravenous) prior to the initiation of prophylactic antibiotic administration; (4) patients who continued to receive antibiotics beyond 48 hours postoperatively following prophylactic administration; (5) patients deemed inappropriate for inclusion by the principal investigator.

Design outcomes

Primary

Measure	Time frame
Proportion and Incidence of Surgical Site Infections Within 30 Days After Surger	—

Secondary

Measure	Time frame
Incidence of Cases Requiring Antibiotic Administration Within 30 Days Postoperatively and Associated Sites of Infection Proportion of ESBL-producing Organisms, CRE, MRSA, and Multidrug-resistant Pseudomonas aeruginosa Among the Top Three Isolated Pathogens in SSI Cultures Incidence of Clostridioides difficile Infection (CDI) Within 30 Days Postoperatively Incidence of Suspected Antibiotic-induced Allergic Reactions or Rash Within 30 Days After Surgery	—

Measure

Time frame

Incidence of Cases Requiring Antibiotic Administration Within 30 Days Postoperatively and Associated Sites of Infection Proportion of ESBL-producing Organisms, CRE, MRSA, and Multidrug-resistant Pseudomonas aeruginosa Among the Top Three Isolated Pathogens in SSI Cultures Incidence of Clostridioides difficile Infection (CDI) Within 30 Days Postoperatively Incidence of Suspected Antibiotic-induced Allergic Reactions or Rash Within 30 Days After Surgery

—

Countries

Japan

Contacts

Public ContactHiroaki Hata

National Hospital Organization, Kyoto Medical Center Dept. of Surgery, Infection Control and Prevention

hhata-kyt@umin.ac.jp0756419161

Outcome results