Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of the Philippines
ClinicalTrials.gov Identifier:
NCT01558986
First received: March 15, 2012
Last updated: March 19, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Surgical Infection
Procedure: Cefazolin
Procedure: Sterile water
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Prevention
Official Title: A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Resource links provided by NLM:


Further study details as provided by University of the Philippines:

Primary Outcome Measures:
  • Surgical Site Infection (as defined by the Centers for Disease Control and Prevention) [ Time Frame: Wounds were assessed on the first post-operative day, then patients were followed-up every week after discharge for the duration of 30 days ] [ Designated as safety issue: Yes ]

    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


Enrollment: 254
Study Start Date: December 2007
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm
Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision
Procedure: Cefazolin
Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
Placebo Comparator: Placebo Arm
Patients to receive sterile water only within 30 minutes prior to skin incision
Procedure: Sterile water
Patients received sterile water only within 30 minutes prior to skin incision

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01558986

Locations
Philippines
Philippine General Hospital - University of the Philippines Manila
Manila, Philippines, 1000
Sponsors and Collaborators
University of the Philippines
Investigators
Principal Investigator: Nelson C Cabaluna, Doctor of Medicine University of the Philippines Manila
  More Information

No publications provided by University of the Philippines

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of the Philippines
ClinicalTrials.gov Identifier: NCT01558986     History of Changes
Other Study ID Numbers: NIH 2007-07-10-02
Study First Received: March 15, 2012
Last Updated: March 19, 2012
Health Authority: Philippines: UP Manila National Institutes of Health - Research Management Committee

Keywords provided by University of the Philippines:
Antibiotic prophylaxis
surgical site infection
modified radical mastectomy
Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer

Additional relevant MeSH terms:
Anti-Bacterial Agents
Cefazolin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 22, 2014