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Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00467948
Enrollment
90
Registered
2007-05-01
Start date
2004-06-30
Completion date
2006-03-31
Last updated
2007-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngeal Cancer

Keywords

clean contaminated, laryngectomy, wound infection

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.

Interventions

DRUGcefazolin

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
wound infectionprospective

Secondary

MeasureTime frame
drug complication3 week after surgery

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026