NCT00467948CompletedPhase 3
Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery
Tehran University of Medical Sciences1 site in 1 country90 target enrollmentStarted: June 1, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- wound infection
Study Overview
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 documented, controversy exists in the optimal antibiotic regimen
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
wound infection
Time Frame: prospective
Secondary Outcomes
- drug complication(3 week after surgery)
Investigators
Study Sites (1)
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