Reusable Versus Disposable Draping System in Breast Reconstruction Surgery

Subjects enrolled in the study will be randomized into two groups. One group will have the
reusable draping system during surgery which the investigators currently use and the second
group will have the disposable draping system. Subjects will be blinded to the type of
draping system used. Subjects are under anesthesia at the time the surgical drapes are
placed. After the subject has signed the informed consent, they will be assigned a study
number for that surgery. The study number will correlate to an envelope which will contain
information on the type of draping system to be used. Subjects enrolled, may be randomized
more than once. Subjects will typically have a minimum of two surgeries, the placement of the
tissue expanders and then the removal of the expanders and placement of the breast implants.
Subjects will not be required to sign another consent form but will be randomized prior to
each surgery. Surgeons who have subjects in the disposable draping system will use a
disposable draping kit that includes gowns for the surgeons and also towels. For subjects who
are having a mastectomy and then the placement of tissue expanders, after the mastectomy has
been performed, the plastic surgeons will use all new draping, towels and gowns to perform
tissue expander placement. A swab will be taken on the wound site to determine if there are
any CFUs (colony forming units) present. The swab will then be placed in a tube containing
1ml of TSB (triptic soy broth). The tube will then be sonicated , and then vortexed for 15
seconds. A 0.1ml aliquot of the solution will be placed in a blood agar plate and incubated
for 48 hours to determine the CFU count. The remainder of the solution will be frozen. In the
event an infection occurs, molecular matching will be done on the culture to determine if it
is from the same exact culture. Rodac plates will be used to test for the presence of
bacterial cultures on the surgeon's gown (Forearm [volar surface]) and glove (palm of
surgeon's dominate hand) and also the subject's surgical drape (Area over sternum). These
will be incubated for 48 hours to determine the CFU count. This process will be repeated at
the second surgery.

Inclusion Criteria:

Females ages 18 years of age and older who are having a mastectomy with tissue expander
placement and for breast implants for reconstruction, which would include immediate or
delayed reconstruction.

Exclusion Criteria:

Male subjects are excluded from this study, while some males do have breast cancer, this is
a rare occurrence and they do not undergo reconstruction surgery with expanders and breast
implants. Females under the age of 18 are excluded as well as females who undergo a
mastectomy but do not have any reconstruction surgery. Females who otherwise meet the
criteria but have an active infection, currently on antibiotics to treat an infection,
urinary tract infections, soft tissue infections or pneumonia are also excluded until they
are approved for surgery by the physician.