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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

Study Interventions

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)

Study Arms

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

Study Status

Unknown status

Start Date: January 2014

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: surgical site infection

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Yasmin Maor, MD

Lead Sponsor: Sheba Medical Center

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02012517

Discuss Cephalexin