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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chlorhexidine irrigation
triple antibiotic irrigation
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring tissue expander, breast reconstruction

Eligibility Criteria

18 Years - 81 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chlorhexidine irrigation

triple antibiotic irrigation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Surgical Site Infection
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.

Secondary Outcome Measures

Number of Participants With Flap Necrosis, Hematoma, and Seroma
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.

Full Information

First Posted
March 17, 2015
Last Updated
January 22, 2022
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02395614
Brief Title
Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
tissue expander, breast reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine irrigation
Arm Type
Experimental
Arm Description
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.
Arm Title
triple antibiotic irrigation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine irrigation
Other Intervention Name(s)
CHG
Intervention Description
- 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.
Intervention Type
Drug
Intervention Name(s)
triple antibiotic irrigation
Other Intervention Name(s)
gentamicin, cefazolin and bacitracin
Intervention Description
-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
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Site Infection
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants With Flap Necrosis, Hematoma, and Seroma
Description
At all postoperative visits with the reconstructive surgeon, patients were thoroughly examined for presence of necrosis, seroma, or hematoma.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
81 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kent Higdon, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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