Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 81
Updated:3/15/2019
Start Date:December 2015
End Date:December 2022
Contact:Kent Higdon, MD
Email:kent.higdon@vanderbilt.edu
Phone:615-936-0160

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Incidence of Surgical Site Infection After Irrigation of Surgical Pocket With 0.05% Chlorhexidine Compared to Triple Antibiotic Solution in Post-mastectomy Breast Reconstruction

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.

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.

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
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Phone: 615-936-0160
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