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Completed

NCT Number: NCT01805856

Antimicrobial Prophylaxis 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.

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Key information

Conditions

Thyroid Disease Endocrine System Diseases Infections Parathyroid Disease Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Thyroid Diseases Wound Infection

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ito Hospital

Tokyo, 150-8308, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PIPC piperacillin sodium

Drug

Other names: PIPC, piperacillin sodium

CEZ, cefazolin sodium

Drug

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ito Hospital

Other

Registry information

Official study title

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

Acronym: Ito-RCT1

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 6, 2013
Registry last updated
Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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