Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Laryngeal Cancer | Drug: cefazolin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
| Official Title: | Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery |
- wound infection [ Time Frame: prospective ]
- drug complication [ Time Frame: 3 week after surgery ]
| Enrollment: | 90 |
| Study Start Date: | June 2004 |
| Study Completion Date: | March 2006 |
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
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| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts 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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00467948
| Iran, Islamic Republic of | |
| Imam khomaini hospital | |
| Tehran, Iran, Islamic Republic of, 19799 | |
| 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 |
| First Submitted: | April 29, 2007 |
| First Posted: | May 1, 2007 |
| Last Update Posted: | July 25, 2007 |
| Last Verified: | June 2003 |
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 |