Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

NCT ID: NCT01805856

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-05-31

Brief Summary

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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

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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.

Conditions

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Thyroid Disease Parathyroid Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A (intervention PIPC)

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 Type EXPERIMENTAL

PIPC piperacillin sodium

Intervention Type DRUG

Group B (intervention CEZ)

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.

Group Type EXPERIMENTAL

CEZ, cefazolin sodium

Intervention Type DRUG

Group C (without AMP)

Patients in Group C underwent surgery without any AMP.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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PIPC piperacillin sodium

Intervention Type DRUG

CEZ, cefazolin sodium

Intervention Type DRUG

Other Intervention Names

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PIPC, piperacillin sodium

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ito Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Takashi Uruno, MD

Role: PRINCIPAL_INVESTIGATOR

Ito Hospital

Locations

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Ito Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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Ito-RCT1

Identifier Type: -

Identifier Source: org_study_id

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