Clinical trial NCT00356148: The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: breast cancer
breast surgery
clean wound
overweight
prophylaxis
antibiotics
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2006-07-25
Enrollment: 372
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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.

Primary outcomes:
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).
timeFrame: 1 month
Secondary outcomes:
measure: Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).
timeFrame: 1 month
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
affiliation: Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit
name: Bahadir M Gulluoglu, MD, FACS
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1002/14651858.CD005360.pub2.
citation: Gulluoglu BM, Guler SA, Ugurlu MU, Culha G. Efficacy of prophylactic antibiotic administration for breast cancer surgery in overweight or obese patients: a randomized controlled trial. Ann Surg. 2013 Jan;257(1):37-43. doi: 10.1097/SLA.0b013e31826d832d.