Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Surgical Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558986
• Other study ID #: NIH 2007-07-10-02
• Status: Completed
• Phase: Phase 3
• First received: March 15, 2012
• Last updated: March 19, 2012
• Start date: December 2007
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: University of the Philippines
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: UP Manila National Institutes of Health - Research Management Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Infection

Intervention

Procedure:
• Cefazolin
Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
• Sterile water
Patients received sterile water only within 30 minutes prior to skin incision

Locations

Country	Name	City	State
Philippines	Philippine General Hospital - University of the Philippines Manila	Manila

Sponsors (1)

Lead Sponsor	Collaborator
University of the Philippines

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes