Prophylactic Antibiotic Use in Hernioplasty

NCT ID: NCT00636831

Last Updated: 2012-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-01-31

Brief Summary

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

Detailed Description

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Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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cont

Group Type PLACEBO_COMPARATOR

Antibiotic: cefazolin Sodium

Intervention Type DRUG

1g continuous IV at 30 minutes before starting operation

intervention

Group Type ACTIVE_COMPARATOR

Antibiotic: cefazolin Sodium

Intervention Type DRUG

1g continuous IV at 30 minutes before starting operation

Interventions

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Antibiotic: cefazolin Sodium

1g continuous IV at 30 minutes before starting operation

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nihon University

OTHER

Sponsor Role lead

Responsible Party

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Takero Mazaki, MD, PhD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nihon University School of Medicine, Department of Surgery

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Hikari-0701

Identifier Type: -

Identifier Source: org_study_id

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