Clinical trial · Interventional
Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
NCT01558986CI-TRIAL-00006537completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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 randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.
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 |
|---|---|---|---|
| Surgical Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cefazolin | Procedure | — | UNRESOLVED |
| Sterile water | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment Arm
- description
- Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision
- interventionNames
- Procedure: Cefazolin
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Patients to receive sterile water only within 30 minutes prior to skin incision
- interventionNames
- Procedure: Sterile water
Primary outcomes (1)
- measure
- Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
- timeFrame
- Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM. Exclusion Criteria: * Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
References
Publications (1)
- DERIVEDCabaluna ND, Uy GB, Galicia RM, Cortez SC, Yray MD, Buckley BS. A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy. World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5. PMID 23052809