Breast Cancer Clinical Trial

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

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. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

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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.

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Eligibility 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

Study is for people with:

Breast Cancer

Estimated Enrollment:

88

Study ID:

NCT02395614

Recruitment Status:

Completed

Sponsor:

Vanderbilt University Medical Center

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There is 1 Location for this study

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Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

88

Study ID:

NCT02395614

Recruitment Status:

Completed

Sponsor:


Vanderbilt University Medical Center

How clear is this clinincal trial information?

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