Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

Not Applicable

Completed

• Conditions: Thyroid Disease; Parathyroid Disease
• Interventions: Drug: PIPC piperacillin sodium; Drug: CEZ, cefazolin sodium

• Registration Number: NCT01805856
• Lead Sponsor: Ito Hospital

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.

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-05
• Last Update Submitted: 2013-03-05
• Study First Posted: 2013-03-06
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2164

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (intervention PIPC)	PIPC piperacillin sodium	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)	CEZ, cefazolin sodium	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ito Hospital; 🇯🇵 Tokyo, Japan