Back to resultsComparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Primary Purpose
Laryngeal Cancer
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
cefazolin
Sponsored by
About this trial
This is an interventional prevention trial for Laryngeal Cancer focused on measuring clean contaminated, laryngectomy, wound infection
Eligibility 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.
Sites / Locations
- Imam khomaini hospital
Outcomes
Primary Outcome Measures
wound infection
Secondary Outcome Measures
drug complication
Full Information
NCT ID
NCT00467948
First Posted
April 29, 2007
Last Updated
April 30, 2007
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00467948
Brief Title
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
Official Title
Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
June 2003
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laryngeal Cancer
Keywords
clean contaminated, laryngectomy, wound infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cefazolin
Primary Outcome Measure Information:
Title
wound infection
Time Frame
prospective
Secondary Outcome Measure Information:
Title
drug complication
Time Frame
3 week after surgery
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
taghi khorsandi, professor
Organizational Affiliation
tehran university of medical science
Official's Role
Study Chair
Facility Information:
Facility Name
Imam khomaini hospital
City
Tehran
ZIP/Postal Code
19799
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
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