Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy
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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 |
- 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:
- 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
| 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 |
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| Philippines | |
| Philippine General Hospital - University of the Philippines Manila | |
| Manila, Philippines, 1000 | |
| 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 Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013