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Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

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ClinicalTrials.gov Identifier: NCT00467948
Recruitment Status : Completed
First Posted : May 1, 2007
Last Update Posted : May 1, 2007
Sponsor:
Information provided by:
Tehran University of Medical Sciences

Study Description
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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

Condition or disease Intervention/treatment Phase
Laryngeal Cancer Drug: cefazolin Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery
Study Start Date : June 2004
Actual Study Completion Date : March 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. wound infection [ Time Frame: prospective ]

Secondary Outcome Measures :
  1. drug complication [ Time Frame: 3 week after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467948


Locations
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Iran, Islamic Republic of
Imam khomaini hospital
Tehran, Iran, Islamic Republic of, 19799
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
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Study Chair: taghi khorsandi, professor tehran university of medical science
More Information
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ClinicalTrials.gov Identifier: NCT00467948    
Other Study ID Numbers: BS_200306
First Posted: May 1, 2007    Key Record Dates
Last Update Posted: May 1, 2007
Last Verified: June 2003
Keywords provided by Tehran University of Medical Sciences:
clean contaminated, laryngectomy, wound infection
Additional relevant MeSH terms:
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Laryngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Laryngeal Diseases
 Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents