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Completed

NCT Number: NCT00467948

Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Patients who need major head & neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Imam khomaini hospital

Tehran, Tehran Province, 19799, Iran

About this study

Patients undergoing laryngeal oncologic surgery are at relatively high risk of developing complication.

Efficacy of cefazolin as a prophylactic antibiotic in head and neck surgery was reviewed in many researches [6] but considering the costs and morbidities of prolonged antibiotic regimen we have presented a prospective and randomized study in 90 patients comparing the efficacy of 2 day over 5 day protocols.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

e.

  • Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study.

Exclusion criteria

  • Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study.
  • In addition, the following exclusion criteria were taken into account: pregnancy, hypersensitivity to penicillins or cephalosporins, patients who received a systemic antibiotic drug within one week prior to the planned procedure, those who had clinical or laboratory evidence of a preexisting infection or had serious systemic renal disease.

Treatment and study plan

Cefazolin

Drug

Primary outcomes

  1. wound infection

    Time frame: prospective

Secondary outcomes

  1. drug complication

    Time frame: 3 week after surgery

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

Important dates

Study start
2004
Study completion
2006
First posted
May 1, 2007
Registry last updated
May 1, 2007

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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