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Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Supportive care, Treatment Active Not specified Other MAR-YC-2003-0111 NCT00356148

Trial Description

Summary

This is a single center trial to compare the rate of surgical site infection in normal (BMI equal to or less than 25) 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), in the other they do not.

Further Study Information

CONTEXT Although breast surgery is regarded as clean surgery, the actual surgical infection rate is well above accepted range in various series. Retrospective studies showed BMI as one of the factors which may have caused increased SSI rate after breast cancer surgery. Yet, no prospective randomized study assessed the efficacy of chemoprophylaxis during breast surgery in overweight patients.

OBJECTIVE To compare the SSI rate between three groups of early stage breast cancer patients in which two are assigned according to randomization. First, patients are grouped into two according to their BMI. All patients (Group I) with BMI equal to or below 25 do not receive any antibiotics as prophylaxis. Patients with a BMI above 25 are randomly assigned to receive a single dose prophylactic ampicillin /sulbactam combination before surgery or not to receive chemoprophylaxis.

DESIGN, SETTING AND PATIENTS Patient recruitment is still continuing after the study started in October 2003 in order to reach a sample size of 360 patients with BMI over 25. Advanced or distant metastatic stage, receiving neoadjuvant therapy, history of receiving antibiotics within prior 3 months, history of immunodeficiency, having a remote infection and history of reaction to treatment antibiotics are within the exclusion criteria.

INTERVENTIONS All patients are followed for 30 days postoperatively (once in a week at the original surgical unit). Patients and the investigator who inspects all wounds are blinded. The cost of prophylactic antibiotics are compared to the cost of infection treatment (inc. wound care, further antibiotic treatments, hospital visits) in patients who develop SSI.

Eligibility Criteria

Inclusion Criteria:

• Women at any age with early stage breast cancer (stage I-II) and ASA I-II.

Exclusion Criteria:

• DCIS,

• 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

Marmara University Hospital

Bahadir M Gulluoglu, M.D.

Principal Investigator

Bahadir M Gulluoglu, M.D.		Ph: +90 216 327 1010 Ext.228
		Email: bmgulluoglu@marmara.edu.tr

Umit Ugurlu, M.D.		Ph: +90 216 327 1010 Ext.573
		Email: umitugurlu@gmail.com

Turkey
	Istanbul
	Marmara University Hospital
		Bahadir M Gulluoglu, M.D.	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00356148
Information obtained from ClinicalTrials.gov on July 16, 2008