Prophylactic Antibiotic Use in Hernioplasty - Full Text View

Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

This study is currently recruiting participants.

Verified by Nihon Univerity, March 2008

First Received: March 10, 2008 No Changes Posted

Sponsor:	Nihon Univerity
Information provided by:	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:	Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	300
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Takero Mazaki, MD, PhD

81339793611 ext 8112

tmazaki@med.nihon-u.ac.jp

Locations

Japan
Nihon University School of Medicine, Department of Surgery	Recruiting
Tokyo, Japan, 179-0072
Principal Investigator: Takero Mazaki, MD, PhD

Sponsors and Collaborators

Nihon Univerity

More Information

No publications provided

Responsible Party:	Nihon University Nerima-Hikarigaoka Hospital ( Takero Mazaki )
Study ID Numbers:	Hikari-0701
Study First Received:	March 10, 2008
Last Updated:	March 10, 2008
ClinicalTrials.gov Identifier:	NCT00636831 History of Changes
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:

Pathological Conditions, Anatomical
Anti-Infective Agents
Anti-Bacterial Agents
Cefazolin
Therapeutic Uses

Hernia
Hernia, Abdominal
Hernia, Inguinal
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010