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

Phase 3
Not Enrolling
Laryngeal Cancer

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Trial Information

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

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

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.

Inclusion Criteria:


- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

wound infection

Outcome Time Frame:


Principal Investigator

taghi khorsandi, professor

Investigator Role:

Study Chair

Investigator Affiliation:

tehran university of medical science


Iran: Ethics Committee

Study ID:




Start Date:

June 2004

Completion Date:

March 2006

Related Keywords:

  • Laryngeal Cancer
  • clean contaminated, laryngectomy, wound infection
  • Laryngeal Neoplasms