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

Vanderbilt University Medical Center

Status: Completed

Conditions: Breast Cancer

Treatments: Drug: Chlorhexidine irrigation; Drug: triple antibiotic irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02395614

140231

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 patients

Sex: Female

Ages: 18 to 81 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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88 participants in 2 patient groups

Chlorhexidine irrigation

Experimental group

Description:

0.05% chlorhexidine solution (IrriSept®) 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.

Treatment:

Drug: Chlorhexidine irrigation

triple antibiotic irrigation

Active Comparator group

Description:

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.

Treatment:

Drug: triple antibiotic irrigation