Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
Condition: Nonmalignant Breast Conditions; Breast Cancer
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Sodium hypochlorite (Dakin's Solution); Chlorhexidine gluconate disk; Control; Occlusive Adhesive Dressing
Intervention type(s): Device; Device; Procedure; Device
Intervention description(s): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day; Apply one chlorhexidine disk to the intervention drain site(s) and change every three days; 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.; 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.
Other intervention name(s): Dakin's solution; Wound cleanser; BioPatch Protective Disk with CHG; Tegaderm CHG Dressing
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Sodium Hypochlorite; Eusol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Bilateral breast mastectomy; Immediate tissue expanders reconstruction