Phase 4 N=300 Randomized Single-blind Prevention

Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair

Inguinal Hernia

Bottom Line

View on ClinicalTrials.gov: NCT01273818 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Rate of Post-operative Infection

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Gentamicin and cefazolin (Drug); Cefazolin (Drug); Gentamicin (Drug)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: Diskapi Teaching and Research Hospital
Primary completion: Feb 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Rate of Post-operative Infection	—	—
PRIMARY Number of Infections in Each Study Arm	1; 3; 0	0.198

Summary

Aim of this study is to measure the effectiveness of topical gentamicin to prevent post-operative infection in inguinal tension-free hernia repair operation.Secondary aim is, if it is effective as a prophylactic agent, to compare it's effect with intra venous single dose cefazolin sodium prophylaxis.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of inguinal hernia

Exclusion Criteria

Femoral hernia
Emergency cases

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Data sourced from ClinicalTrials.gov (NCT01273818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.