NCT01558986

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: University of the Philippines · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Infection

Interventions

Type	Name	Description
PROCEDURE	Cefazolin	Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
PROCEDURE	Sterile water	Patients received sterile water only within 30 minutes prior to skin incision

Timeline

• Start date: 2007-12-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2012-03-20
• Last updated: 2012-03-20

Locations

1 site across 1 country: Philippines