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

Primary Purpose

Thyroid Disease, Parathyroid Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
PIPC piperacillin sodium
CEZ, cefazolin sodium
Sponsored by
Ito Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thyroid Disease focused on measuring antimicrobial prophylaxis, AMP, surgical site infection, SSI, thyroid, thyroidectomy, parathyroid, surgery

Eligibility Criteria

10 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Ito Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group A (intervention PIPC)

Group B (intervention CEZ)

Group C (without AMP)

Arm 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.

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.

Patients in Group C underwent surgery without any AMP.

Outcomes

Primary Outcome Measures

Surgical site infections after thyroid and parathyroid surgery
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

Side effect of the drug for Antimicrobial prophylaxis
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.

Full Information

First Posted
March 5, 2013
Last Updated
March 5, 2013
Sponsor
Ito Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01805856
Brief Title
Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
Acronym
Ito-RCT1
Official Title
Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ito Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Disease, Parathyroid Disease
Keywords
antimicrobial prophylaxis, AMP, surgical site infection, SSI, thyroid, thyroidectomy, parathyroid, surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A (intervention PIPC)
Arm Type
Experimental
Arm 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.
Arm Title
Group B (intervention CEZ)
Arm Type
Experimental
Arm 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.
Arm Title
Group C (without AMP)
Arm Type
No Intervention
Arm Description
Patients in Group C underwent surgery without any AMP.
Intervention Type
Drug
Intervention Name(s)
PIPC piperacillin sodium
Other Intervention Name(s)
PIPC, piperacillin sodium
Intervention Type
Drug
Intervention Name(s)
CEZ, cefazolin sodium
Primary Outcome Measure Information:
Title
Surgical site infections after thyroid and parathyroid surgery
Description
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.
Time Frame
1 month after operation
Secondary Outcome Measure Information:
Title
Side effect of the drug for Antimicrobial prophylaxis
Description
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.
Time Frame
4 days after operation
Other Pre-specified Outcome Measures:
Title
Urinary tract infection after operation with or without antimicrobial prophylaxis
Description
If the patients had a symptom of urinary tract infection, additional blood test and urine test were done to diagnose infection accurately.
Time Frame
1month after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Uruno, MD
Organizational Affiliation
Ito Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ito Hospital
City
Tokyo
ZIP/Postal Code
150-8308
Country
Japan

12. IPD Sharing Statement

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Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery

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