Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

This study has been completed.

Sponsor:

Information provided by:

Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT00467948

First received: April 29, 2007

Last updated: April 30, 2007

Last verified: June 2003

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

Resource links provided by NLM:

Drug Information available for: Cefazolin Cefazolin sodium

Genetic and Rare Diseases Information Center resources: Laryngeal Cancer

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


Ages Eligible for Study:	Child, Adult, Senior
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


ClinicalTrials.gov Identifier:	NCT00467948 History of Changes
Other Study ID Numbers:	BS_200306
Study First Received:	April 29, 2007
Last Updated:	April 30, 2007

Keywords provided by Tehran University of Medical Sciences:


clean contaminated, laryngectomy, wound infection

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on June 28, 2017

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