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
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