At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 372 enrolled
Drug / intervention
Ampicillin/Sulbactamdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 4 clinical trial evaluating Ampicillin/Sulbactam for Breast Cancer. Completed, enrolled 372 participants across 1 site.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesTurkey (Türkiye)
Collaborators--
Timeline
Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2003
First PostedJul 2006
Primary CompletionMar 2010
Study CompletionMay 2010
TodayJul 2026
First PostedJul 25, 2006
Enrollment StartOct 1, 2003
Primary CompletionMar 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 19.9 years ago
Interventions
Ampicillin/Sulbactamdrug
Ampicillin/Sulbactam 1 gr, once within onr hour before surgery