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


Phase 3
18 Years
80 Years
Not Enrolling
Female
Surgical Infection

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Trial Information

A Randomized, Double Blinded Placebo-Controlled Trial on the Routine Use of 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 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Surgical Site Infection (as defined by the Centers for Disease Control and Prevention)

Outcome 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

Outcome 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

Safety Issue:

Yes

Principal Investigator

Nelson C Cabaluna, Doctor of Medicine

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of the Philippines Manila

Authority:

Philippines: UP Manila National Institutes of Health - Research Management Committee

Study ID:

NIH 2007-07-10-02

NCT ID:

NCT01558986

Start Date:

December 2007

Completion Date:

September 2011

Related Keywords:

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

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