Surgical Site Infections
Conditions
Keywords
surgical site infection, breast reconstruction, drains, prophylaxis
Brief summary
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.
Interventions
DRUGProlonged antibiotic treatment
DRUGShort antibiotic course (standard of care)
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| surgical site infection | 1 year | The percentage and number of surgical site infections assessed according to the NNIS criteria up to one year after reconstructive breast surgery will be compared between the two groups |
Countries
Israel
Contacts
Primary ContactYasmin Maor, MD
Outcome results
None listed