Thyroid Disease Clinical Trial
Official title:
Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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