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

Information source: Vanderbilt University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Chlorhexidine irrigation (Drug); triple antibiotic irrigation (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Kent Higdon, MD, Study Director, Affiliation: Vanderbilt University

Overall contact:
Maksym Yezhelyev, MD, PhD, Phone: 615-936-0198, Email: maksym.v.yezhelyev@vanderbilt.edu

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: frequency of surgical site infection as defined by CDC

Detailed description: 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 Department of Plastic Surgery at Vanderbilt University routinely irrigates surgically created breast pockets with triple antibiotics solution (1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline). The investigators' current postoperative infection rate is 14%. Recently, several reports demonstrated exceptional antiseptic properties of chlorhexidine derivatives. Chlorhexidine (CHG) at a concentration of 0. 05% has been found to be nontoxic to granulation tissue and wound healing. 8 Exposure to a concentration of 0. 05% CHG effectively produced a 5- to 6-log reduction in microbial with 0. 05% chlorhexidine compared to triple antibiotic solution in post-mastectomy breast reconstruction. Potential benefit of using 0. 05% CHG solution to reduce postoperative infection rate after breast reconstruction procedures has not been elucidated and currently is not a standard of care. The investigators hypothesize that intraoperative irrigation of surgical pocket with 0. 05% CHG solution before insertion of breast TE allows for more significant reduction of postoperative wound infection compared to similar irrigation with triple antibiotic solution in women undergoing bilateral TE-based 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.

Eligibility

Minimum age: 18 Years. Maximum age: 81 Years. Gender(s): Female.

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

Locations and Contacts

Maksym Yezhelyev, MD, PhD, Phone: 615-936-0198, Email: maksym.v.yezhelyev@vanderbilt.edu

Additional Information

Starting date: May 2015
Last updated: March 20, 2015

Page last updated: August 23, 2015

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