Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Thyroid Disease Clinical Trial

— Ito-RCT1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01805856
• Other study ID #: Ito-RCT1
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: March 5, 2013
• Start date: November 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2013
• Source: Ito Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2164
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parathyroid Disease
• Parathyroid Diseases
• Surgical Wound Infection
• Thyroid Disease
• Thyroid Diseases

Intervention

Drug:
• PIPC piperacillin sodium

• CEZ, cefazolin sodium

Locations

Country	Name	City	State
Japan	Ito Hospital	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Ito Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary tract infection after operation with or without antimicrobial prophylaxis	If the patients had a symptom of urinary tract infection, additional blood test and urine test were done to diagnose infection accurately.	1month after operation	No
Primary	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	No
Secondary	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	Yes