Prophylactic Antibiotic Use in Hernioplasty

Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00636831

Acronym

RCT-herniation

Enrollment

400

Registered

2008-03-17

Start date

2007-07-31

Completion date

2012-01-31

Last updated

2012-02-07

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

Conditions

Inguinal Hernia

Keywords

Prophylactic, Antibiotic, Infection, Primary case

Brief summary

The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.

Interventions

DRUGAntibiotic: cefazolin Sodium

1g continuous IV at 30 minutes before starting operation

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Primary inguinal hernia * Elective surgery * Must be older than 20 years of age * Must not have any serious complication

Exclusion criteria

* Incarceration * Recurrence * Drug allergy * Diabetes mellitus * Malignant diseases * Serious heart diseases * Psychological diseases * Pregnancy * Have been medicated with corticosteroids

Design outcomes

Primary

Measure	Time frame
infectious complication	two year

Secondary

Measure	Time frame
Recurrence of inguinal hernia	two year

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026