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Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

Primary Purpose

Surgical Infection

Status
Completed
Phase
Phase 3
Locations
Philippines
Study Type
Interventional
Intervention
Cefazolin
Sterile water
Sponsored by
University of the Philippines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Infection focused on measuring Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Philippine General Hospital - University of the Philippines Manila

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment Arm

Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 15, 2012
Last Updated
March 19, 2012
Sponsor
University of the Philippines
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1. Study Identification

Unique Protocol Identification Number
NCT01558986
Brief Title
Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
Official Title
A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Philippines

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Infection
Keywords
Antibiotic prophylaxis, surgical site infection, modified radical mastectomy, Prevention of surgical site infection (SSI) in patients undergoing MRM for breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Active Comparator
Arm Description
Patients to receive intravenous cefazolin 1 gram within 30 minutes prior to skin incision
Arm Title
Placebo Arm
Arm Type
Placebo Comparator
Arm Description
Patients to receive sterile water only within 30 minutes prior to skin incision
Intervention Type
Procedure
Intervention Name(s)
Cefazolin
Intervention Description
Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
Intervention Type
Procedure
Intervention Name(s)
Sterile water
Intervention Description
Patients received sterile water only within 30 minutes prior to skin incision
Primary Outcome Measure Information:
Title
Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)
Description
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
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nelson C Cabaluna, Doctor of Medicine
Organizational Affiliation
University of the Philippines Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philippine General Hospital - University of the Philippines Manila
City
Manila
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

Citations:
PubMed Identifier
23052809
Citation
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.
Results Reference
derived

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Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

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