Prophylactic Antibiotic Use in Hernioplasty

Inguinal Hernia Clinical Trial

— RCT-herniation  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636831
• Other study ID #: Hikari-0701
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2008
• Last updated: February 6, 2012
• Start date: July 2007
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: Nihon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Nihon University School of Medicine Herima-Hikarigaoka Hospital
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Antibiotic: cefazolin Sodium
1g continuous IV at 30 minutes before starting operation

Locations

Country	Name	City	State
Japan	Nihon University School of Medicine, Department of Surgery	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Nihon University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	infectious complication		two year	Yes
Secondary	Recurrence of inguinal hernia		two year	No