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

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ClinicalTrials.gov Identifier: NCT02395614
Recruitment Status : Recruiting
First Posted : March 23, 2015
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Kent Higdon, Vanderbilt University Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Chlorhexidine irrigation Drug: triple antibiotic irrigation Not Applicable

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 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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019


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 Name: 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 Name: gentamicin, cefazolin and bacitracin




Primary Outcome Measures :
  1. frequency of surgical site infection as defined by CDC [ Time Frame: 30 days ]
    frequency of surgical site infection (as defined by CDC, http://www.cdc.gov/hai/ssi/ssi.html)



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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02395614


Contacts
Contact: Kent Higdon, MD 615-936-0160 kent.higdon@vanderbilt.edu
Contact: Julia Yao, BSN 615-343-8426 jun.yao@vumc.org

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Kent Higdon, MD    615-936-0160    kent.higdon@vanderbilt.edu   
Contact: Marcia Spear, DNP    615-343-8426    marcia.spear@vanderbilt.edu   
Sponsors and Collaborators
Vanderbilt University Medical Center
Investigators
Principal Investigator: Kent Higdon, MD Vanderbilt University Medical Center

Responsible Party: Kent Higdon, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT02395614     History of Changes
Other Study ID Numbers: 140231
First Posted: March 23, 2015    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kent Higdon, Vanderbilt University Medical Center:
tissue expander
breast reconstruction

Additional relevant MeSH terms:
Surgical Wound Infection
Wound Infection
Infection
Postoperative Complications
Pathologic Processes
Pharmaceutical Solutions
Anti-Bacterial Agents
Gentamicins
Cefazolin
Bacitracin
Neomycin
Polymyxin B
Bacitracin zinc, neomycin sulfate, polymyxin B, drug combination
Antibiotics, Antitubercular
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Antitubercular Agents
Anti-Infective Agents, Local
Disinfectants
Dermatologic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action