Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery (Ito-RCT1)
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|ClinicalTrials.gov Identifier: NCT01805856|
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Disease Parathyroid Disease||Drug: PIPC piperacillin sodium Drug: CEZ, cefazolin sodium||Not Applicable|
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.
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Experimental: Group A (intervention PIPC)
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.
Drug: PIPC piperacillin sodium
Other Name: PIPC, piperacillin sodium
Experimental: Group B (intervention CEZ)
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.
Drug: CEZ, cefazolin sodium
No Intervention: Group C (without AMP)
Patients in Group C underwent surgery without any AMP.
- 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.
- 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.
- Urinary tract infection after operation with or without antimicrobial prophylaxis [ Time Frame: 1month after operation ]If the patients had a symptom of urinary tract infection, additional blood test and urine test were done to diagnose infection accurately.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805856
|Tokyo, Japan, 150-8308|
|Principal Investigator:||Takashi Uruno, MD||Ito Hospital|