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Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

NCT01558986 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2012-03-20

No results posted yet for this study

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

Interventions

PROCEDURE

Cefazolin

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

PROCEDURE

Sterile water

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

Sponsors & Collaborators

  • University of the Philippines

    lead OTHER

Principal Investigators

  • Nelson C Cabaluna, Doctor of Medicine · University of the Philippines Manila

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • Philippines

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01558986 on ClinicalTrials.gov