Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

This study has been completed.

First Received: April 29, 2007 Last Updated: April 30, 2007 History of Changes

Sponsor:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00467948

Purpose

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	Intervention	Phase
Laryngeal Cancer	Drug: cefazolin	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cancer Surgery

Drug Information available for: Cefazolin Cefazolin sodium

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

wound infection [ Time Frame: prospective ]

Secondary Outcome Measures:

drug complication [ Time Frame: 3 week after surgery ]

Enrollment:	90
Study Start Date:	June 2004
Study Completion Date:	March 2006

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467948

Locations

Iran, Islamic Republic of
Imam khomaini hospital
tehran, Iran, Islamic Republic of, 19799

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair:

taghi khorsandi, professor

tehran university of medical science

More Information

No publications provided

Study ID Numbers:	BS_200306
Study First Received:	April 29, 2007
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00467948 History of Changes
Health Authority:	Iran: Ethics Committee

Keywords provided by Tehran University of Medical Sciences:

clean contaminated, laryngectomy, wound infection

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Anti-Infective Agents
Otorhinolaryngologic Neoplasms
Otorhinolaryngologic Diseases
Laryngeal Neoplasms
Pharmacologic Actions
Anti-Bacterial Agents

Neoplasms
Neoplasms by Site
Cefazolin
Respiratory Tract Diseases
Head and Neck Neoplasms
Therapeutic Uses
Laryngeal Diseases

ClinicalTrials.gov processed this record on February 08, 2010