Clinical trial · Interventional
The Efficacy of Prophylactic Antibiotic Administration During Breast Cancer Surgery in Overweight Patients.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ampicillin/Sulbactam | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Prophylaxis Group
- description
- patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
- interventionNames
- Drug: Ampicillin/Sulbactam
- type
- NO_INTERVENTION
- label
- No Prophylaxis Group
- description
- Patients who are BMI over 25 and do not receive antibiotic prophylaxis
Primary outcomes (1)
- measure
- 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).
- timeFrame
- 1 month
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDCunningham 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. PMID 16625637
- DERIVEDGulluoglu 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. PMID 23001082