Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
Condition: Breast Cancer
MeSH terms: Surgical Wound Infection
Study type: Interventional

Summary: 
      The investigators intend to perform a prospective randomized study and compare the incidence
      of surgical wound infection between mastectomy wounds irrigated with triple antibiotic
      solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast
      reconstruction. Each patient will receive triple antibiotic solution on one breast and the
      CHG on the other breast.
    

Detailed description: 
      Breast reconstruction with tissue expander (TE) remains the gold standard of breast
      restoration after mastectomy. During the first stage of reconstruction, a TE is placed under
      chest muscles and slowly inflated postoperatively over the period of several weeks. After
      desired volume of TE is achieved it is exchanged for permanent breast prosthesis during
      another surgery (second stage of reconstruction). Postoperative wound infection after
      placement of TE can lead to devastating consequences both for patients and a surgeon.
      Frequently, surgical site infection requires additional surgeries and resulting in the
      removal of TE and long term IV antibiotic therapy. Therefore, during breast reconstruction
      procedures all possible measures are implemented to reduce postoperative infection rate.
      Several studies demonstrated that intra-operative irrigation of surgical wounds with
      antibiotic containing solution before insertion of breast TE decreases postoperative
      infection rate. This approach is currently adopted as a standard of care within plastic
      surgery clinical community.

      The investigators intend to perform a prospective randomized study and compare the incidence
      of surgical wound infection between mastectomy wounds irrigated with triple antibiotic
      solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast
      reconstruction.
    

Intervention name(s): Chlorhexidine irrigation; triple antibiotic irrigation
Intervention type(s): Drug; Drug
Intervention description(s): - 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.; -triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket
Other intervention name(s): CHG; gentamicin, cefazolin and bacitracin
Intervention MeSH terms: Anti-Bacterial Agents; Gentamicins; Cefazolin; Bacitracin; Chlorhexidine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tissue expander; breast reconstruction