NCT01805856

Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,164 (actual)
• Sponsor: Ito Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.

Detailed description

Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP. Exclusion criteria * Patients who did not agree to attend the randomized control study. * Patients who received the operation including mediastinum with sternotomy. * Patients who received the operation including additional resection of trachea, esophagus and larynx. * Patients who received the re-operation for post-operative bleedings. * Patients who had known allergy to cephem or penicillin.

Conditions

• Thyroid Disease
• Parathyroid Disease

Interventions

Type	Name	Description
DRUG	PIPC piperacillin sodium
DRUG	CEZ, cefazolin sodium

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2013-03-06
• Last updated: 2013-03-06

Locations

1 site across 1 country: Japan