Prophylactic Antibiotic Use in Hernioplasty (RCT-herniation)

Nihon University

Status and phase: Completed; Phase 3

Conditions: Inguinal Hernia

Treatments: Drug: Antibiotic: cefazolin Sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00636831

Hikari-0701

Details and patient eligibility

About

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

Enrollment: 400 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

400 participants in 2 patient groups, including a placebo group

cont

Placebo Comparator group

Treatment:

Drug: Antibiotic: cefazolin Sodium

intervention

Active Comparator group

Treatment:

Drug: Antibiotic: cefazolin Sodium