Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Phase 3

Completed

• Conditions: Laryngeal Cancer

• Registration Number: NCT00467948
• Lead Sponsor: Tehran University of Medical Sciences

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 Timeline

• Status Verified: 2003-06
• Study Start: 2004-06
• Study Completion: 2006-03
• Study First Submitted: 2007-04-29
• Study First Submitted QC: 2007-04-30
• Last Update Submitted: 2007-04-30
• Study First Posted: 2007-05-01
• Last Update Posted: 2007-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
wound infection	prospective

Secondary Outcome Measures

Name	Time	Method
drug complication	3 week after surgery

Trial Locations

Locations (1)

Imam khomaini hospital; 🇮🇷 Tehran, Iran, Islamic Republic of