Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Information source: Tehran University of Medical Sciences
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Laryngeal Cancer
Intervention: cefazolin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Tehran University of Medical Sciences Official(s) and/or principal investigator(s):
taghi khorsandi, professor, Study Chair, Affiliation: tehran university of medical science
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 documented, controversy exists in the optimal antibiotic regimen
Clinical Details
Official title: Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery
Study design: Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: wound infection
Secondary outcome: drug complication
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
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Imam khomaini hospital, tehran 19799, Iran, Islamic Republic of
Additional Information
Starting date: June 2004
Ending date: March 2006
Last updated: April 30, 2007
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