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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01805856
Recruitment Status : Completed
First Posted : March 6, 2013
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thyroid Disease Parathyroid Disease Drug: PIPC piperacillin sodium Drug: CEZ, cefazolin sodium Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
Study Start Date : November 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine


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 Name: 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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   10 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805856


Locations
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Japan
Ito Hospital
Tokyo, Japan, 150-8308
Sponsors and Collaborators
Ito Hospital
Investigators
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Principal Investigator: Takashi Uruno, MD Ito Hospital
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Responsible Party: Ito Hospital
ClinicalTrials.gov Identifier: NCT01805856    
Other Study ID Numbers: Ito-RCT1
First Posted: March 6, 2013    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013
Keywords provided by Ito Hospital:
antimicrobial prophylaxis
AMP
surgical site infection
SSI
thyroid
thyroidectomy
parathyroid
surgery
Additional relevant MeSH terms:
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Thyroid Diseases
Parathyroid Diseases
Endocrine System Diseases
Cefazolin
Piperacillin
Anti-Bacterial Agents
Anti-Infective Agents