Trial Information

Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

This study entitled "The Quantification of Breast Sensations Following Postmastectomy Breast
Reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in
the nonreconstructed breast. Touch, vibration, pain and temperature sensation will be
objectively evaluated greater than 1 year following completion of reconstruction. Breast
sensation following immediate, tissue expander/implant breast reconstruction will be
compared with that following immediate, autogenous tissue reconstruction.

A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate
touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of
vibratory sensation. Temperature sensation will be evaluated by application of warm and cool
stimuli. Superficial pain sensation will be evaluated by application of sharp and dull
stimuli.

A patient reported assessment of sensory changes in the breast will be administered to
patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence,
severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient
Demographic and Treatment Information Form" and patients' medical records will be used to
obtain demographic and treatment data. The role of confounding variables (including: patient
age, breast volume, axillary procedures performed and adjuvant therapies received) on the
recovery of sensation will be evaluated.

The estimated accrual time for this study is 12 months.