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

January 22, 2022 updated by: Kent Higdon, Vanderbilt University Medical Center

Post-Mastectomy Surgical Pocket Irrigation With Triple Antibiotic Solution vs Chlorhexidine Gluconate: A Randomized Controlled Trial Assessing Surgical Site Infections in Immediate Tissue Expander 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 81 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chlorhexidine irrigation
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.
Drug: Chlorhexidine irrigation
- 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Other Names:
  • CHG
ACTIVE_COMPARATOR: triple antibiotic irrigation
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.
Drug: triple antibiotic irrigation

-triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.

80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket

Other Names:
  • gentamicin, cefazolin and bacitracin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Surgical Site Infection
Time Frame: 6 months
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of SSI (cellulitis, purulent drainage). SSI was defined as any instance where antibiotics were restarted or where erythema, cellulitis, warmth, purulent drainage, or fever occurred. SSI was further classified in 3 categories: minor when requiring oral antibiotics, major when requiring inpatient intravenous antibiotics or operative washout, and finally, explantation.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Flap Necrosis, Hematoma, and Seroma
Time Frame: 6 months
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Investigators

  • Principal Investigator: Kent Higdon, MD, Vanderbilt University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

March 17, 2015

First Submitted That Met QC Criteria

March 20, 2015

First Posted (ESTIMATE)

March 23, 2015

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2022

Last Update Submitted That Met QC Criteria

January 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 140231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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