Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

NCT01558986 | Completed Phase 3 DMC

• 1 other identifier: NIH 2007-07-10-02
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Infection

Keywords

Antibiotic prophylaxis; surgical site infection; modified radical mastectomy; Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days

Study Arms (2)

Treatment Arm

ACTIVE COMPARATOR

Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision

Procedure: Cefazolin

Placebo Arm

PLACEBO COMPARATOR

Patients to receive sterile water only within 30 minutes prior to skin incision

Procedure: Sterile water

Interventions

Cefazolin PROCEDURE

Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;

Treatment Arm

Sterile water PROCEDURE

Patients received sterile water only within 30 minutes prior to skin incision

Placebo Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the Philippines: lead

Study Sites (1)

Philippine General Hospital - University of the Philippines Manila

Manila, 1000, Philippines

Location

Related Publications (1)

• Cabaluna 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 DERIVED

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Nelson C Cabaluna, Doctor of Medicine

  University of the Philippines Manila

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2012
• First Posted: March 20, 2012
• Study Start: December 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: March 20, 2012

Record last verified: 2012-03

Locations

PH (1)