Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Conditions
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Nonmalignant Breast Conditions, Breast Cancer

Intervention / Treatment
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* Device: Sodium hypochlorite (Dakin's Solution)
* Device: Chlorhexidine gluconate disk
* Procedure: Control
* Device: Occlusive Adhesive Dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antisepsis Side<br>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. | Device: Sodium hypochlorite (Dakin's Solution)<br>* 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day<br>* Other names: Wound cleanser;Device: Chlorhexidine gluconate disk<br>* Apply one chlorhexidine disk to the intervention drain site(s) and change every three days<br>* Other names: BioPatch Protective Disk with CHG;Device: Occlusive Adhesive Dressing<br>* 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.<br>* Other names: Tegaderm CHG Dressing;|
| Other: Control Side<br>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. | Procedure: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Per Drain Analysis: Drain Bulb Fluid Colonization at Approximately 1 Week |  | Approximately 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of Subjects With Surgical Site Infection Within 30 Days |  | Approximately 30 days after surgery | 
| 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 | 
| Per Drain Analysis: Drain Bulb Fluid Colonization at Removal |  | Approximately one month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bilateral breast mastectomy, Immediate tissue expanders reconstruction