Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded were patients with significant co-morbid factors, for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to cephalosporins, and those with local infection. Patients were randomized to receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for the presence of SSI and other complications weekly for 30 days.

Official Title
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A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Conditions
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Surgical Infection

Intervention / Treatment
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* Procedure: Cefazolin
* Procedure: Sterile water


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Arm<br>Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision | Procedure: Cefazolin<br>* Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;<br>|
| Placebo Comparator: Placebo Arm<br>Patients to receive sterile water only within 30 minutes prior to skin incision | Procedure: Sterile water<br>* Patients received sterile water only within 30 minutes prior to skin incision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) | Mastectomy wounds were evaluated for the presence of SSI as defined by the Center for Disease Control and Prevention meeting the following criteria: infection that occurred within 30 days after the operative procedure and at least one of the following: purulent drainage (culture documentation not required) organism isolated from fluid/tissue of incision site at least one sign of inflammation (erythema, local warmth of wound, induration) wound is deliberately opened by the surgeon physician declares the wound infected | Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer