Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients
This study has been completed.
Sponsor:
Tehran University of Medical Sciences
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
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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 Endpoint Classification: Safety/Efficacy Study 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:
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 |
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
| ClinicalTrials.gov Identifier: | NCT00467948 History of Changes |
| Other Study ID Numbers: | BS_200306 |
| Study First Received: | April 29, 2007 |
| Last Updated: | April 30, 2007 |
| Health Authority: | Iran: Ethics Committee |
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 Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013