Official Title: “Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a BMI Over 25.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Ampicillin/Sulbactam
  • Ampicillin/Sulbactam 1 gr, once within onr hour before surgery

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
• No Intervention: 2
  • Patients who are BMI over 25 and do not receive antibiotic prophylaxis

Primary Measures

• Surgical site infection rates in patients with BMI over 25: the risk ratio (RR) contrasting the rate in the prophylaxis group to the rate in the placebo group, and the 95% CIs for the RR.
  • Time Frame: 1 month
    Safety Issue?: Yes

Secondary Measures

• The risk ratio (RR) contrasting the surgical site infection rate in the group with BMI over 25 who received placebo to the rate in the group with normal BMI.
  • Time Frame: 1 month
    Safety Issue?: Yes
• Cost-effectiveness of receiving antibiotic prophylaxis in overweight patients.
  • Time Frame: 1 month
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Marmara University School of Medicine

Overall Clinical Trial Officials and Contacts

Bahadir M Gulluoglu, M.D. Principal Investigator Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit  

Overall Contact: Bahadir M Gulluoglu, M.D. +90 216 327 1010 bmgulluoglu@marmara.edu.tr

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00356148

Study ID Number: MAR-YC-2003-0111

ClinicalTrials.gov Identifier: NCT00356148

Health Authority: Turkey: Ministry of Health