NCT01805856

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

1.5 years

First QC Date

March 5, 2013

Last Update Submit

March 5, 2013

Conditions

Thyroid DiseaseParathyroid Disease

Keywords

antimicrobial prophylaxisAMPsurgical site infectionSSIthyroidthyroidectomyparathyroidsurgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month after operation

Secondary Outcomes (1)

  • Side effect of the drug for Antimicrobial prophylaxis

    4 days after operation

Other Outcomes (1)

  • Urinary tract infection after operation with or without antimicrobial prophylaxis

    1month after operation

Study Arms (3)

Group A (intervention PIPC)

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.

Drug: PIPC piperacillin sodium

Group B (intervention CEZ)

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.

Drug: CEZ, cefazolin sodium

Group C (without AMP)

NO INTERVENTION

Patients in Group C underwent surgery without any AMP.

Interventions

PIPC piperacillin sodiumDRUG
Also known as: PIPC, piperacillin sodium
Group A (intervention PIPC)
CEZ, cefazolin sodiumDRUG
Group B (intervention CEZ)

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ito Hospital

Tokyo, 150-8308, Japan

Location

MeSH Terms

Conditions

Thyroid DiseasesParathyroid DiseasesSurgical Wound Infection

Interventions

PiperacillinCefazolin

Condition Hierarchy (Ancestors)

Endocrine System DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCephalosporinsThiazines

Study Officials

  • Takashi Uruno, MD

    Ito Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 6, 2013

Study Start

November 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

JP(1)