The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
Information source: Marmara University School of Medicine
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Ampicillin/Sulbactam (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Marmara University School of Medicine Official(s) and/or principal investigator(s):
Bahadir M Gulluoglu, M.D., Principal Investigator, Affiliation: Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit
Overall contact:
Bahadir M Gulluoglu, M.D., Phone: +90 216 327 1010, Ext: 228, Email: bmgulluoglu@marmara.edu.tr
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.
Clinical Details
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.
Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.Cost-effectiveness of receiving antibiotic prophylaxis in overweight patients.
Detailed description:
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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.
Locations and Contacts
Bahadir M Gulluoglu, M.D., Phone: +90 216 327 1010, Ext: 228, Email: bmgulluoglu@marmara.edu.tr
Marmara University Hospital, Istanbul 34662, Turkey; Recruiting
Bahadir M Gulluoglu, M.D., Principal Investigator
Additional Information
Related publications: Cunningham M, Bunn F, Handscomb K. Prophylactic antibiotics to prevent surgical site infection after breast cancer surgery. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD005360. Review.
Starting date: October 2003
Ending date: January 2010
Last updated: May 21, 2008
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