Tumescent Antibiotic SSI Prophylaxis (Cefazolin): Protocol Outline
Study Design Overview
Patient Population: Female Breast Cancer Patients Undergoing Mastectomy
End Point: Dicotomous Variable: Presence or Absence of Any Post-Op SSI within 30 days of Surgery.
Multivariate Logistic Regression?
Covariate: Chemotherapy, Radiation Therapy, Age, Immunosuppressant Drugs (Prednisone, etc)
Prospective
Randomized Allocation
Blinded (3-treatment options):
¥Control: Standard IV Prophylaxis Regimen: IV Cefazolin 1gm given 60 to 30 minutes before ÒBlade-to-SkinÓ. No Tumescent Infiltration.
¥TLA: Tumescent Local Anesthesia (without Subq Cefazolin) Plus Standard IV Prophylaxis
Regimen.
¥TLAC: Tumescent Local Anesthesia containing 1 gm Cefazolin, but No IV Cefazolin.
Internet Based communication with clinicians
Including recruitment of clinical/surgical participants
Multicenter