The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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 cancer surgery. The overweight patients are further randomized into two groups; in one group patients receive prophylactic antibiotics (ampicillin/sulbactam; Prophylaxis Group), in the other they do not (No Prophylaxis Group).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marmara University
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Sulbactam; Sultamicillin

Criteria

Inclusion Criteria:

• Women at any age with early stage breast cancer (stage I-II) and American Society of Anesthesiologists (ASA) score of I-II.

Exclusion Criteria:

• 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.