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Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
This study has been completed.
Study NCT00467948   Information provided by Tehran University of Medical Sciences
First Received: April 29, 2007   Last Updated: April 30, 2007   History of Changes

April 29, 2007
April 30, 2007
June 2004
 
wound infection [ Time Frame: prospective ]
Same as current
Complete list of historical versions of study NCT00467948 on ClinicalTrials.gov Archive Site
drug complication [ Time Frame: 3 week after surgery ]
Same as current
 
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

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

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.

Phase III
Interventional
Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Laryngeal Cancer
Drug: cefazolin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
90
March 2006
 

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.
Both
 
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00467948
 
BS_200306
Tehran University of Medical Sciences
 
Study Chair: taghi khorsandi, professor tehran university of medical science
Tehran University of Medical Sciences
June 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP