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NCT Number: NCT01558986

Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Philippine General Hospital - University of the Philippines Manila

Manila, 1000, Philippines

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cefazolin

Procedure

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

Sterile water

Procedure

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

Primary outcomes

  1. 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

    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

Sponsors and collaborators

Lead sponsor

University of the Philippines

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Mar 20, 2012
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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