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| Tracking Information | |||||
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| First Received Date ICMJE | April 29, 2007 | ||||
| Last Updated Date | April 30, 2007 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
wound infection [ Time Frame: prospective ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00467948 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
drug complication [ Time Frame: 3 week after surgery ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients | ||||
| Official Title ICMJE | Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery | ||||
| 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 |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Prevention, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Laryngeal Cancer | ||||
| Intervention ICMJE | Drug: cefazolin | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | March 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:e.
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00467948 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | BS_200306 | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||
| Verification Date | June 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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