Trial | NCT01805856  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    2164
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.
Study Started
Nov 30
2010
Primary Completion
May 31
2012
Study Completion
May 31
2012
Last Update
Mar 06
2013
Estimate

Drug PIPC piperacillin sodium

  • Other names: PIPC, piperacillin sodium

Drug CEZ, cefazolin sodium

Group A (intervention PIPC) Experimental

Patients in group A (intervention PIPC) were given AMP of 2g PIPC intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose PIPC was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.

Group B (intervention CEZ) Experimental

Patients in Group B (intervention CEZ) were given AMP of 1g CEZ intravenously just after intubation. If the operation time was longer than 3 hours, additional infusion of same dose CEZ was done. After coming back to the patients' own room, one more infusion of same dose of same drug was done.

Group C (without AMP) No Intervention

Patients in Group C underwent surgery without any AMP.

Criteria 

Inclusion Criteria:

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.

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.
No Results Posted