Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 81 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • females between 18 - 81 years of age
  • and are undergoing bilateral mastectomy
  • and are candidates for immediate breast reconstruction with tissue expanders.

Exclusion Criteria

  • females younger than 18 and older than 81 years of age;
  • undergoing unilateral mastectomy and reconstruction;
  • bilateral reconstruction using other techniques,
  • patients allergic to one or more components of the antibiotic solution;
  • allergy to CHG

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Chlorhexidine irrigation
0.05% chlorhexidine solution (IrriSeptĀ®) commercially prepared in 450 ml bottles for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
  • Drug: Chlorhexidine irrigation
    - 0.05% chlorhexidine solution (IrriSeptĀ®) 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.
    Other names:
    • CHG
Active Comparator
triple antibiotic irrigation
triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline (NS). If the patient is allergic to either component - the allergen will not be used in the solution - for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
  • Drug: triple antibiotic irrigation
    -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 names:
    • gentamicin, cefazolin and bacitracin

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232
Contact:
Kent Higdon, MD
615-936-0160
kent.higdon@vanderbilt.edu

More Details

NCT ID
NCT02395614
Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Kent Higdon, MD
615-936-0160
kent.higdon@vanderbilt.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.