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

NCT ID: NCT00356148

Last Updated: 2013-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 372 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2010-05-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Prophylaxis Group

patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis

Group Type: ACTIVE_COMPARATOR

Ampicillin/Sulbactam

Intervention Type: DRUG

Ampicillin/Sulbactam 1 gr, once within onr hour before surgery

No Prophylaxis Group

Patients who are BMI over 25 and do not receive antibiotic prophylaxis

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ampicillin/Sulbactam

Ampicillin/Sulbactam 1 gr, once within onr hour before surgery

Intervention Type: DRUG

Other Intervention Names

Ampisid 1 gr

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Bahadir M. Gulluoglu, M.D.

Prof Bahadir M Gulluoglu, MD, FACS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bahadir M Gulluoglu, MD, FACS

Role: STUDY_CHAIR

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

Locations

Marmara University Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 16625637 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23001082 (View on PubMed)

Other Identifiers

MAR-YC-2003-0111

Identifier Type: -

Identifier Source: org_study_id