Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Breast Cancer Clinical Trial

Official title:

Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286168
• Other study ID #: 10-008061
• Secondary ID: UL1TR000135
• Status: Completed
• Phase: Phase 2
• First received: January 26, 2011
• Last updated: December 3, 2014
• Start date: May 2011
• Est. completion date: November 2013

Study information

• Verified date: December 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Surgical site infection (SSI) after breast and axillary surgery occurs more often than for other clean surgical procedures. Infection in the setting of a tissue expander can be devastating and can lead to early implant loss and failed reconstruction. Surgical drains have been noted as a potential source for surgical site infections. Hypothesis: Bacteria present in surgical drains after tissue expander reconstruction may be decreased by simple and inexpensive local antiseptic interventions.

Description:

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 care.

Methods:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Nonmalignant Breast Conditions

Intervention

Device:
• Sodium hypochlorite (Dakin's Solution)
10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
• Chlorhexidine gluconate disk
Apply one chlorhexidine disk to the intervention drain site(s) and change every three days

Procedure:
• Control
Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.

Device:
• Occlusive Adhesive Dressing
A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota
United States	UCSF	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	Ethicon, Inc., University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week	Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed at variable times across patients, per clinical indication. When clinically indicated, some patients did have their drains removed at the one week visit, in which case they only had one bulb fluid culture.	Approximately 1 week after surgery	No
Primary	Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week		Approximately 1 week after surgery	No
Secondary	Number of Subjects With Drain Tubing Colonization at Removal	Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.	Approximately two weeks after surgery	No
Secondary	Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal	Bacterial growth was defined as plate growth of 1+ or greater. Drains were removed a variable times across patients, per clinical indication. A second bulb culture was obtained later than 1 week ONLY in those drains that were not removed at 1 week.	Approximately 2 weeks after surgery	No
Secondary	Number of Subjects With Surgical Site Infection Within 30 Days		Approximately 30 days after surgery	No
Secondary	Number of Subjects With Surgical Site Infection Within 1 Year		Approximately one year after surgery	No
Secondary	Per Drain Analysis: Drain Tubing Colonization at Removal		Approximately one month after surgery	No
Secondary	Per Drain Analysis: Drain Bulb Fluid Colonization at Removal		Approximately one month after surgery	No