At a glance
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Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction
In Brief
A Phase 2 clinical trial evaluating Sodium hypochlorite (Dakin's Solution), Chlorhexidine gluconate disk, and 2 other interventions for Nonmalignant Breast Conditions and Breast Cancer. Completed, enrolled 110 participants across 2 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.