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

NCT00356148 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2013-01-30

Study results available
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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).

Conditions

Interventions

DRUG

Ampicillin/Sulbactam

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

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Principal Investigators

  • Bahadir M Gulluoglu, MD, FACS · Marmara University School of Medicine, Department of General Surgery, Breast and Endocrine Surgery Unit

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00356148 on ClinicalTrials.gov