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Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Phase 2
18 Years
90 Years
Open (Enrolling)
Nonmalignant Breast Conditions, Breast Cancer

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Trial Information

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Surgical Site infection after breast surgical procedures occurs more frequently than for
other clean surgical procedures. Considering the large numbers of patients who undergo
breast-related procedures per year and the increasing use of immediate breast reconstruction
with placement of tissue expanders or immediate implant reconstruction, a surgical site
infection involving the implant can result in its removal and a failed reconstruction.

The primary aim of the study is to determine if chlorhexidine disk application and
irrigation of the drainage bulb with dilute Dakin's solution (buffered sodium hypochlorite
solution)after tissue expander breast reconstruction or immediate implant reconstruction,
effectively decreases rates of bacterial colonization in drain fluid compared to standard

Secondary aims:

1. To determine baseline rates of bacterial colonization of drain fluid and drain tubing
after tissue expander breast reconstruction.

2. To determine if bacterial colonization of fluid in the drain bulb correlates with
bacterial colonization of internal segments of the drain catheter within the wound

3. To determine if interventions directed at drain antisepsis are associated with reduced
rates of bacterial growth from tissue expander biofilm.


Eighty-five patients undergoing bilateral immediate reconstruction with tissue expander
placement will have one surgical site treated with standard drain care and the other treated
with a drain antisepsis regimen. Drain antisepsis intervention will consist of two measures:
1) placement of a chlorhexidine sponge dressing at the drain exit site, and 2) twice daily
irrigation of the drainage bulb with dilute Dakin's solution (buffered hypochlorite).

All patients will undergo semiquantitative cultures of the drain bulb at one week
postoperatively. This culture will be repeated at the time of drain removal, with
simultaneous cultures of the fluid in the bulb as well as an internal segment of each
removed drainage tube. All patients will be evaluated for clinical signs of infection and
for any adverse reactions to the drain antisepsis at the follow-up visits.

Inclusion Criteria:

- Females or males age 18-90 able to give informed consent

- Undergoing bilateral mastectomy with immediate expander reconstruction or immediate
implant reconstruction

- May have either malignant or benign breast condition

Exclusion Criteria:

- Antibiotic use in the fourteen days prior to surgical date

- Undergoing unilateral tissue expander reconstruction

- Documented allergy to chlorhexidine gluconate

- Prior radiation therapy to the breast or chest wall (ie for breast conservation or
mantle radiation for Hodgkin's disease)

- Documented allergy to all three of the following antibiotics: cephalosporin,
trimethoprim/sulfamethoxazole, and levofloxacin

- Pregnant women

- Vulnerable subjects - prisoners, institutionalized individuals

- Non-English speaking patients without adequate interpreter assistance

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Outcome Measure:

Decrease bacterial colonization in drain fluid

Outcome Description:

To determine if chlorhexidine disk application and drainage bulb irrigation with dilute Dakin's solution (buffered sodium hypochlorite solution) after tissue expander breast reconstruction effectively decreases bacterial colonization rates of drain fluid compared to standard care

Outcome Time Frame:

Up to one month. The hemovac drains will be in the subject up to one month.

Safety Issue:


Principal Investigator

Amy C Degnim, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic, Rochester, MN


United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

December 2013

Related Keywords:

  • Nonmalignant Breast Conditions
  • Breast Cancer
  • Bilateral breast mastectomy
  • Immediate tissue expanders reconstruction
  • Breast Neoplasms



UCSF San Francisco, California  941430324
Mayo Clinic Rochester, Minnesota  55905