Prophylactic Antibiotic Use in Hernioplasty - Full Text View

Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

This study has been completed.

First Received on March 10, 2008. Last Updated on February 6, 2012 History of Changes

Sponsor:	Nihon Univerity
Information provided by (Responsible Party):	Takero Mazaki, MD, PhD, Nihon Univerity
ClinicalTrials.gov Identifier:	NCT00636831

Purpose

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

Condition	Intervention	Phase
Inguinal Hernia	Drug: Antibiotic: cefazolin Sodium	Phase III

Study Type:	Interventional
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
Official Title:	Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Hernia

Drug Information available for: Cefazolin Cefazolin sodium

U.S. FDA Resources

Further study details as provided by Nihon Univerity:

Primary Outcome Measures:

infectious complication [ Time Frame: two year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Recurrence of inguinal hernia [ Time Frame: two year ] [ Designated as safety issue: No ]

Enrollment:	400
Study Start Date:	July 2007
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: cont	Drug: Antibiotic: cefazolin Sodium 1g continuous IV at 30 minutes before starting operation
Active Comparator: intervention	Drug: Antibiotic: cefazolin Sodium 1g continuous IV at 30 minutes before starting operation

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636831

Locations

Japan
Nihon University School of Medicine, Department of Surgery
Tokyo, Japan, 179-0072

Sponsors and Collaborators

Nihon Univerity

More Information

No publications provided

Responsible Party:	Takero Mazaki, MD, PhD, Dr, Nihon Univerity
ClinicalTrials.gov Identifier:	NCT00636831 History of Changes
Other Study ID Numbers:	Hikari-0701
Study First Received:	March 10, 2008
Last Updated:	February 6, 2012
Health Authority:	Japan: Nihon University School of Medicine Herima-Hikarigaoka Hospital

Keywords provided by Nihon Univerity:

Prophylactic
Antibiotic
Infection
Primary case

Additional relevant MeSH terms:

Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal
Anti-Bacterial Agents

Cefazolin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012