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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00356148
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Information provided by (Responsible Party):
Bahadir M. Gulluoglu, M.D., Marmara University

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 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ampicillin/Sulbactam Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 372 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Study Start Date : October 2003
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Arm Intervention/treatment
Active Comparator: Prophylaxis Group
patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
Drug: Ampicillin/Sulbactam
Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
Other Name: Ampisid 1 gr

No Intervention: No Prophylaxis Group
Patients who are BMI over 25 and do not receive antibiotic prophylaxis

Primary Outcome Measures :
  1. 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). [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00356148

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Marmara University Hospital
Istanbul, Turkey, 34662
Sponsors and Collaborators
Marmara University
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Study Chair: Bahadir M Gulluoglu, MD, FACS Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bahadir M. Gulluoglu, M.D., Prof Bahadir M Gulluoglu, MD, FACS, Marmara University Identifier: NCT00356148     History of Changes
Other Study ID Numbers: MAR-YC-2003-0111
First Posted: July 25, 2006    Key Record Dates
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013
Last Verified: December 2012
Keywords provided by Bahadir M. Gulluoglu, M.D., Marmara University:
breast cancer
breast surgery
clean wound
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action