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

March 5, 2013 updated by: Ito Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 150-8308
        • Ito Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 90 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: PIPC piperacillin sodium
Other Names:
  • PIPC, piperacillin sodium
Experimental: 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.
Drug: CEZ, cefazolin sodium
No Intervention: Group C (without AMP)
Patients in Group C underwent surgery without any AMP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical site infections after thyroid and parathyroid surgery
Time Frame: 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.
1 month after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side effect of the drug for Antimicrobial prophylaxis
Time Frame: 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.
4 days after operation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary tract infection after operation with or without antimicrobial prophylaxis
Time Frame: 1month after operation
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ito Hospital

Investigators

  • Principal Investigator: Takashi Uruno, MD, Ito Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 5, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ito-RCT1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Disease

Clinical Trials on PIPC piperacillin sodium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe