UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058179 |
|---|---|
| Receipt number | R000066508 |
| Scientific Title | Impact of Alternative Prophylactic Antibiotics on Surgical Site Infections During a Cefazolin Shortage: A Retrospective Cohort Study in Gastrointestinal Surgery |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/06/15 11:20:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Impact of Alternative Prophylactic Antibiotics on Surgical Site Infections During a Cefazolin Shortage: A Retrospective Cohort Study in Gastrointestinal Surgery
Acronym
Impact of Alternative Prophylactic Antibiotics During Cefazolin Shortage in Gastrointestinal Surgery
Scientific Title
Impact of Alternative Prophylactic Antibiotics on Surgical Site Infections During a Cefazolin Shortage: A Retrospective Cohort Study in Gastrointestinal Surgery
Scientific Title:Acronym
Impact of Alternative Prophylactic Antibiotics During Cefazolin Shortage in Gastrointestinal Surgery
Region
| Japan |
Condition
Condition
Gastrointestinal surgery
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surgical site infection (SSI) remains a major concern as one of the leading causes of healthcare-associated infections. Current clinical guidelines recommend cefazolin (CEZ) as the first-line agent for prophylactic antibiotic use in many surgical procedures due to its proven efficacy. However, in 2019, a shortage of CEZ occurred, lasting approximately 10 months, during which alternative antibiotics had to be used for surgical prophylaxis.
This study aims to compare the incidence of SSIs during the CEZ shortage period with that of the periods before and after the shortage, and to evaluate the prophylactic efficacy of CEZ versus alternative antibiotics. The findings may help inform strategies for prioritizing the allocation of CEZ to surgical procedures or conditions where it is most effective during future supply disruptions, as well as identify potential alternative prophylactic antibiotics that can be used in place of CEZ.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion and Incidence of Surgical Site Infections Within 30 Days After Surger
Key secondary outcomes
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
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hata |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Dept. of Surgery, Infection Control and Prevention
Zip code
612-8555
Address
1-1, Fushimi-ku Fukakusa Mukaihata-cho, Kyoto, Kyoto, Japan
TEL
0756419161
hhata-kyt@umin.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hata |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Dept. of Surgery, Infection Control and Prevention
Zip code
612-8555
Address
1-1, Fushimi-ku Fukakusa Mukaihata-cho, Kyoto, Kyoto, Japan
TEL
0756419161
Homepage URL
hhata-kyt@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Health Organization Clinical Research Central Ethics Review Board
Address
2-5-21, Higashigaoka, Meguro-ku, Tokyo
Tel
03-5712-5050
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 15 | Day |
Last modified on
| 2025 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066508
