Nashville, Tennessee 37232


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.


Study summary:

Breast reconstruction with tissue expender (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.


Criteria:

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


NCT ID:

NCT02395614


Primary Contact:

Principal Investigator
Kent Higdon, MD
Vanderbilt University Medical Center

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


Backup Contact:

Email: marcia.spear@vanderbilt.edu
Marcia Spear, DNP
Phone: 615-343-8426


Location Contact:

Nashville, Tennessee 37232
United States

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

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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