Clinical Trial: Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Ito Hospital

Current Primary Outcome: Surgical site infections after thyroid and parathyroid surgery [ Time Frame: 1 month after operation ]

Surgical site infection was defined as patients who are necessary to receive the treatment such as surgical drainage or antibiotic medication. When the patients receive the surgical drainage, microbial culture was performed.


Original Primary Outcome: Same as current

Current Secondary Outcome: Side effect of the drug for Antimicrobial prophylaxis [ Time Frame: 4 days after operation ]

The appearances of drug allergic reactions (skin rash and anaphylactic shock) were checked at operating room. Blood test to check up liver and renal dysfunction was done on the 3rd POD. Liver and renal dysfunction is clinically diagnosed by patients' own physicians and the author, and only counted the cases which function got worse compared to preoperative data.


Original Secondary Outcome: Same as current

Information By: Ito Hospital

Dates:
Date Received: March 5, 2013
Date Started: November 2010
Date Completion:
Last Updated: March 5, 2013
Last Verified: March 2013