Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
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
1. To determine baseline rates of bacterial colonization of drain fluid and drain tubing
after tissue expander breast reconstruction.
2. To determine if bacterial colonization of fluid in the drain bulb correlates with
bacterial colonization of internal segments of the drain catheter within the wound
3. To determine if interventions directed at drain antisepsis are associated with reduced
rates of bacterial growth from tissue expander biofilm.
Eighty-five 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention
Decrease bacterial colonization in drain fluid
To determine if chlorhexidine disk application and drainage bulb irrigation with dilute Dakin's solution (buffered sodium hypochlorite solution) after tissue expander breast reconstruction effectively decreases bacterial colonization rates of drain fluid compared to standard care
Up to one month. The hemovac drains will be in the subject up to one month.
Amy C Degnim, M.D.
Mayo Clinic, Rochester, MN
United States: Food and Drug Administration
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