Status:
COMPLETED
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Lead Sponsor:
Tehran University of Medical Sciences
Conditions:
Laryngeal Cancer
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 doc...
Detailed Description
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 man...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00467948
Start Date
June 1 2004
End Date
March 1 2006
Last Update
May 1 2007
Active Locations (1)
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1
Imam khomaini hospital
Tehran, Tehran Province, Iran, 19799