Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

November 30, 2013

Study Completion Date

November 30, 2013

Conditions
Nonmalignant Breast ConditionsBreast Cancer
Interventions
DEVICE

Sodium hypochlorite (Dakin's Solution)

10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day

DEVICE

Chlorhexidine gluconate disk

Apply one chlorhexidine disk to the intervention drain site(s) and change every three days

PROCEDURE

Control

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.

DEVICE

Occlusive Adhesive Dressing

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.

Trial Locations (2)

55904

Mayo Clinic, Rochester

94107

UCSF, San Francisco

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

University of California, San Francisco

OTHER

collaborator

Ethicon, Inc.

INDUSTRY

lead

Mayo Clinic

OTHER