Completed

Ito-RCT1Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery

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What is being tested

PIPC piperacillin sodium

+ CEZ, cefazolin sodium

Drug
Who is being recruted

Endocrine System Diseases+6

+ Infections

+ Pathologic Processes

From 10 to 90 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2010
See protocol details

Summary

Principal SponsorIto Hospital
Last updated: March 6, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2010

Actual date on which the first participant was enrolled.

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.

NCT01805856
Principal SponsorIto Hospital
Last updated: March 6, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2164 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 10 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Endocrine System DiseasesInfectionsPathologic ProcessesPostoperative ComplicationsPathological Conditions, Signs and SymptomsWound InfectionParathyroid DiseasesSurgical Wound InfectionThyroid Diseases

Criteria

1 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
Patients who did not agree to attend the randomized control study
Patients who had known allergy to cephem or penicillin
Patients who received the operation including additional resection of trachea, esophagus and larynx
Patients who received the operation including mediastinum with sternotomy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
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 II

Experimental
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 III

No Intervention
Patients in Group C underwent surgery without any AMP.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Ito Hospital

Tokyo, JapanOpen Ito Hospital in Google Maps
CompletedOne Study Center