Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Phase 2

Completed

Conditions: Nonmalignant Breast Conditions
Breast Cancer

Interventions: Device: Sodium hypochlorite (Dakin's Solution)
Procedure: Control
Device: Chlorhexidine gluconate disk
Device: Occlusive Adhesive Dressing

Registration Number: NCT01286168

Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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 & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 110

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

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Antisepsis Side	Chlorhexidine gluconate disk	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. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Antisepsis Side	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. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Antisepsis Side	Sodium hypochlorite (Dakin's Solution)	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. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.
Control Side	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.

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Approximately 1 Week	Approximately 1 week after surgery	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.
Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week	Approximately 1 week after surgery

Secondary Outcome Measures

Name	Time	Method
Per Drain Analysis: Drain Bulb Fluid Colonization at Removal	Approximately one month after surgery
Number of Subjects With Surgical Site Infection Within 30 Days	Approximately 30 days after surgery
Number of Subjects With Drain Bulb Fluid Bacterial Colonization at Removal	Approximately 2 weeks after surgery	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.
Number of Subjects With Drain Tubing Colonization at Removal	Approximately two weeks after surgery	Drain tubing colonization was defined as greater than 50 colony forming units. Drains were removed at variable timepoints based on the clinical situation.
Number of Subjects With Surgical Site Infection Within 1 Year	Approximately one year after surgery
Per Drain Analysis: Drain Tubing Colonization at Removal	Approximately one month after surgery