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Sponsored by: |
Marmara University School of Medicine |
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Information provided by: | Marmara University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00356148 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Ampicillin/Sulbactam |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 360 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
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Drug: Ampicillin/Sulbactam
Ampicillin/Sulbactam 1 gr, once within onr hour before surgery
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2: No Intervention
Patients who are BMI over 25 and do not receive antibiotic prophylaxis
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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.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bahadir M Gulluoglu, M.D. | +90 216 327 1010 ext 228 | bmgulluoglu@marmara.edu.tr |
Contact: Umit Ugurlu, M.D. | +90 216 327 1010 ext 573 | umitugurlu@gmail.com |
Turkey | |
Marmara University Hospital | Recruiting |
Istanbul, Turkey, 34662 | |
Principal Investigator: Bahadir M Gulluoglu, M.D. |
Principal Investigator: | Bahadir M Gulluoglu, M.D. | Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit |
Responsible Party: | Marmara University School of Medicine ( Bahadir M Gulluoglu, MD, FACS ) |
Study ID Numbers: | MAR-YC-2003-0111 |
Study First Received: | July 24, 2006 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00356148 History of Changes |
Health Authority: | Turkey: Ministry of Health |
breast cancer breast surgery clean wound |
overweight prophylaxis antibiotics |
Anti-Infective Agents Anti-Bacterial Agents Skin Diseases Ampicillin Breast Neoplasms |
Sultamicillin Overweight Breast Diseases Sulbactam |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Skin Diseases Breast Neoplasms Ampicillin Sultamicillin Enzyme Inhibitors |
Pharmacologic Actions Sulbactam Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Breast Diseases |