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

NCT02395614 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2022-01-26

Study results available
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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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Kent Higdon, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
81 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02395614 on ClinicalTrials.gov