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Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias

D

Diskapi Teaching and Research Hospital

Status and phase

Completed
Phase 4

Conditions

Inguinal Hernia

Treatments

Drug: sefazolin

Study type

Interventional

Funder types

Other

Identifiers

NCT01264003
DEAH-1002-IHR

Details and patient eligibility

About

Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when prosthetic materials are used. This prospective randomized study has been set to observe if antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.

Full description

There are two group in the study. Control group received no antibiotic prohylaxis, whereas a single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the study. 30-days surgical site infection rates and 1 year prosthetic intervention late infection rates are observed and recorded. Side effects of antibiotic used are also recorded.

Enrollment

200 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: inguinal hernia repair -

Exclusion Criteria: uncontrolled diabetes mellitus,

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

200 participants in 1 patient group

1
Active Comparator group
Description:
Antibiotic prohylaxis / Lichtenstein repair
Treatment:
Drug: sefazolin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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