Surgical Site Infections | Antibiotic Prophylaxis in Prosthetic Breast Reconstructions
Surgical Site Infections research study
What is the primary objective of this study?
The added benefit of prolonged antibiotic prophylactic treatment in patients undergoing breast reconstruction who have drains placed for several days after surgery is controversial. In this study we aim to compare two prophylactic regimens: 1. 24 hour antibiotic treatment prior to surgery with cefazolin 2. a prolonged antibiotic regimen consisting of 48 hours cefazolin treatment followed by oral therapy with cephalexin until the removal of the drains. Patients will sign an informed consent form prior to the surgery and will be randomized to one of the antibiotic regimens. Patients will be closely followed up to one year after surgery. The number of surgical site infections according to the NNIS criteria and loss of breast implants will be compared between the two groups.
Who is eligible to participate?
Inclusion Criteria: All criteria should be present: 1. Signing an informed consent form 2. Reconstructive breast surgery 3. One drain or more remained after surgery - Exclusion Criteria: Age < 18 years Active infection at the surgical site at the operation time or in close proximity to the surgical site Immune deficiency state
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Surgical Site Infections
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Prolonged antibiotic treatment
Drug:Short antibiotic course (standard of care)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
short antibiotic courseIntravenous 2 gram cefazolin every 8 hours for 24 hours beginning at surgery
Prolonged antobiotic treatmentIntravenous 2 gram cefazolin every 8 hours for 48 hours starting at surgery followed by oral cefalexin 500 mg every 6 hours until removal of drains
Start Date: January 2014
Completed Date: December 2017
Phase: Phase 4
Primary Outcome: surgical site infection
Study sponsors, principal investigator, and references
Principal Investigator: Yasmin Maor, MD
Lead Sponsor: Sheba Medical Center