Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Study Overview
=================
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 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.

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

Conditions
-----------------
Thyroid Disease, Parathyroid Disease

Intervention / Treatment
-----------------
* Drug: PIPC piperacillin sodium
* Drug: CEZ, cefazolin sodium


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (intervention PIPC)<br>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<br> <br> * Other names: PIPC, piperacillin sodium;|
| Experimental: Group B (intervention CEZ)<br>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<br> <br> |
| No Intervention: Group C (without AMP)<br>Patients in Group C underwent surgery without any AMP. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infections after thyroid and parathyroid surgery | 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. | 1 month after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effect of the drug for Antimicrobial prophylaxis | 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. | 4 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SSI, antimicrobial prophylaxis, AMP, surgical site infection, thyroid, thyroidectomy, parathyroid, surgery