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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00356148
Recruitment Status : Completed
First Posted : July 25, 2006
Results First Posted : January 30, 2013
Last Update Posted : January 30, 2013
Sponsor:
Information provided by (Responsible Party):
Bahadir M. Gulluoglu, M.D., Marmara University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Prevention
Condition Breast Cancer
Intervention Drug: Ampicillin/Sulbactam
Enrollment 372
Recruitment Details Patients were recruited at a tertiary university teaching hospital between October 2003 and March 2010.
Pre-assignment Details Patients having male gender, diagnosis of Stage 0, locally advanced or bilateral breast cancer, receiving neoadjuvant treatment, planning to undergo reconstructive surgery, having immunodeficiency, receiving antibiotics during previous one month, undergoing breast / axilla operation before randomization, denying to provide consent were excluded.
Arm/Group Title Prophylaxis Group No Prophylaxis Group
Hide Arm/Group Description patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis Patients who are BMI over 25 and do not receive antibiotic prophylaxis
Period Title: Overall Study
Started 189 183
Completed 187 182
Not Completed 2 1
Reason Not Completed
Reoperation within 30 days             2             1
Arm/Group Title Prophylaxis Group No Prophylaxis Group Total
Hide Arm/Group Description patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis Patients who are BMI over 25 and do not receive antibiotic prophylaxis Total of all reporting groups
Overall Number of Baseline Participants 189 183 372
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 189 participants 183 participants 372 participants
59.1  (11.1) 56.9  (14.1) 57.5  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 189 participants 183 participants 372 participants
Female
189
 100.0%
183
 100.0%
372
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title 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).
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was intent-to-treat
Arm/Group Title Prophylaxis Group No Prophylaxis Group
Hide Arm/Group Description:
patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
Patients who are BMI over 25 and not receive antibiotic prophylaxis
Overall Number of Participants Analyzed 187 182
Measure Type: Number
Unit of Measure: participants
9 25
2.Secondary Outcome
Title Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group).
Hide Description [Not Specified]
Time Frame 1 month
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prophylaxis Group No Prophylaxis Group
Hide Arm/Group Description:
patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
Patients who are BMI over 25 and not receiving antibiotic prophylaxis
Overall Number of Participants Analyzed 187 182
Mean (Standard Error)
Unit of Measure: Monetary unit in Turkish Liras
30  (5.6) 13  (3.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prophylaxis Group No Prophylaxis Group
Hide Arm/Group Description patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis Patients who are BMI over 25 and do not receive antibiotic prophylaxis
All-Cause Mortality
Prophylaxis Group No Prophylaxis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prophylaxis Group No Prophylaxis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/189 (0.00%)   0/183 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Prophylaxis Group No Prophylaxis Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/189 (0.00%)   0/183 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Prof. Bahadir M Gulluoglu
Organization: Marmara University School of Medicine
Phone: 902164256565 ext 4012
Responsible Party: Bahadir M. Gulluoglu, M.D., Marmara University
ClinicalTrials.gov Identifier: NCT00356148     History of Changes
Other Study ID Numbers: MAR-YC-2003-0111
First Submitted: July 24, 2006
First Posted: July 25, 2006
Results First Submitted: April 20, 2012
Results First Posted: January 30, 2013
Last Update Posted: January 30, 2013