Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Nonmalignant Breast Conditions

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01286168

UL1TR000135 (U.S. NIH Grant/Contract)

10-008061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Antisepsis Side

Experimental group

Description:

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.

Treatment:

Device: Chlorhexidine gluconate disk

Device: Sodium hypochlorite (Dakin's Solution)

Device: Occlusive Adhesive Dressing

Control Side

Other group

Description:

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.

Treatment:

Procedure: Control