Phase 4
N=372
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00356148 ↗Enrolled (actual)
372
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcome: Primary: 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). — 9; 25 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ampicillin/Sulbactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Marmara University
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
9; 25 | — |
| SECONDARY Overall SSI-related Prophylaxis and Treatment Cost in Patients With BMI Over 25 Who Received Prophylaxis (Prophylaxis Group) and Not (No Prophylaxis Group). |
30; 13 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT00356148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.