Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Laryngeal Cancer Clinical Trial

Official title:

Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467948
• Other study ID #: BS_200306
• Status: Completed
• Phase: Phase 3
• First received: April 29, 2007
• Last updated: April 30, 2007
• Start date: June 2004
• Est. completion date: March 2006

Study information

• Verified date: June 2003
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Laryngeal Cancer

Intervention

Drug:
• cefazolin

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam khomaini hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	wound infection		prospective
Secondary	drug complication		3 week after surgery