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Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a Body Mass Index (BMI) Over 25.

Phase 4
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Phase IV Study of Determining the Efficacy of Ampicillin/Sulbactam Combination as Antibiotic Prophylaxis During Breast Cancer Surgery in Patients With a Body Mass Index (BMI) Over 25.

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 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 (Control Group) 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
(Prophylaxis Group) or not to receive chemoprophylaxis (No Prophylaxis Group).

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.
Cost of SSI-related prophylaxis and treatments (including additional hospital visits after
discharge, physician charges, additional antibiotics, wound management, other drugs and
interventions etc) is calculated in each study group and compared with each other.

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Number of Patients With Body Mass Index (BMI) Over 25 Who Developed Surgical Site Infection (SSI) in Groups Who Received Antibiotic Prophylaxis (Prophylaxis Group) and no Prophylaxis (No Prophylaxis Group).

Outcome Time Frame:

1 month

Safety Issue:


Principal Investigator

Bahadir M Gulluoglu, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit


Turkey: Ministry of Health

Study ID:




Start Date:

October 2003

Completion Date:

May 2010

Related Keywords:

  • Breast Cancer
  • breast cancer
  • breast surgery
  • clean wound
  • overweight
  • prophylaxis
  • antibiotics
  • Breast Neoplasms