Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Phase 3

Completed

• Conditions: Surgical Infection
• Interventions: Procedure: Cefazolin; Procedure: Sterile water

• Registration Number: NCT01558986
• Lead Sponsor: University of the Philippines

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-03
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-19
• Last Update Submitted: 2012-03-19
• Study First Posted: 2012-03-20
• Last Update Posted: 2012-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm	Cefazolin	Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision
Placebo Arm	Sterile water	Patients to receive sterile water only within 30 minutes prior to skin incision

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)	Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days	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: 1. purulent drainage (culture documentation not required); 2. organism isolated from fluid/tissue of incision site; 3. at least one sign of inflammation (erythema, local warmth of wound, induration); 4. wound is deliberately opened by the surgeon; 5. physician declares the wound infected

Trial Locations

Locations (1)

Philippine General Hospital - University of the Philippines Manila; 🇵🇭 Manila, Philippines