Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery (Ito-RCT1)

Ito Hospital

Status: Completed

Conditions: Parathyroid Disease; Thyroid Disease

Treatments: Drug: CEZ, cefazolin sodium; Drug: PIPC piperacillin sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT01805856

Ito-RCT1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,164 patients

Sex: All

Ages: 10 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,164 participants in 3 patient groups

Group A (intervention PIPC)

Experimental group

Description:

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.

Treatment:

Drug: PIPC piperacillin sodium

Group B (intervention CEZ)

Experimental group

Description:

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.

Treatment:

Drug: CEZ, cefazolin sodium

Group C (without AMP)

No Intervention group

Description:

Patients in Group C underwent surgery without any AMP.