Parathyroid Disease, Thyroid Disease
Conditions
Keywords
antimicrobial prophylaxis, AMP, surgical site infection, SSI, thyroid, thyroidectomy, 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 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.
Interventions
DRUGPIPC piperacillin sodium
DRUGCEZ, cefazolin sodium
Sponsors
Ito Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infections after thyroid and parathyroid surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side effect of the drug for Antimicrobial prophylaxis | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Urinary tract infection after operation with or without antimicrobial prophylaxis | 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. |
Countries
Japan
Outcome results
None listed