Status:
COMPLETED
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
Lead Sponsor:
Marmara University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
This is a single center trial to compare the rate of surgical site infection (SSI) in normal (BMI equal to or less than 25; Control Group)) and overweight (BMI over 25) women who are undergoing breast...
Detailed Description
CONTEXT Although breast surgery is regarded as clean surgery, the actual SSI rate is well above accepted range in various series. Retrospective studies showed BMI as one of the factors which may have ...
Eligibility Criteria
Inclusion
- Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.
Exclusion
- Ductal carcinoma in situ (DCIS; stage 0 cancer),
- Advanced or distant metastatic stage,
- Receiving any neoadjuvant therapy,
- History of receiving any antibiotics within prior 3 months,
- History of immunodeficiency,
- Having a remote infection,
- History of reaction to study antibiotics,
- Denial of signing the consent form.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
372 Patients enrolled
Trial Details
Trial ID
NCT00356148
Start Date
October 1 2003
End Date
May 1 2010
Last Update
January 30 2013
Active Locations (1)
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1
Marmara University Hospital
Istanbul, Turkey (Türkiye), 34662