Trial of Drain Antisepsis After Tissue Expander Breast Reconstruction

Completed · Phase 2

Conditions studied: Nonmalignant Breast Conditions, Breast Cancer

In brief

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.

Key facts

Study ID: NCT01286168
Run by: Mayo Clinic
People needed: 110
Starts: 2011-05-01
Expected to finish: 2013-11-01
Last updated by the study team: 2014-12-19

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

UCSF — San Francisco, California, United States
Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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