Evaluating the Impact That Personnel Traffic Through the Operating Room Has on Surgical Site Infections

Infections that occur as a direct result of patients' stays in a hospital are called
"nosocomial infections." One of the most common types of nosocomial infections occur as a
result of surgical procedures that patient undergo while they are in the hospital. These
nosocomial infections that occur as a result of surgical procedures are referred to as
surgical site infections (SSI), and they are associated with increased patient morbidity as
well as approximately $1.5 billion of added healthcare expenses annually. Under the nascent
Patient Protection and Affordable Care Act (PPACA), SSI rates will be used by the government
to justify the alteration of reimbursement rates to hospitals and physicians for patient
care. As a result, SSIs are of the utmost interest to both surgeons, hospitals and
healthcare providers, in general.

One of the suspected causes of SSI's is increased personnel traffic thru operating rooms
during surgeries. The logic involves the fact that bacteria capable of causing SSI's are
present in normal air. The air within operating rooms is constantly filtered, in order to
decrease the bacterial load within the air and hopefully decreasing the likelihood that a
patient will develop a SSI. When personnel open doors connecting the operating rooms to the
outside hallways, the dirty, unfiltered air from the hallways is able to mix with the clean,
filtered air within the operating rooms. This increases the bacterial load within the
operating room, and potentially increases the risk of the patient developing a SSI. However,
no class I data exist demonstrating that the level of personnel traffic thru operating rooms
during surgery has any significant effect on SSI's. Nevertheless, the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO) Accreditation Manual for Hospitals, as
well as the United States' Centers for Disease Control (CDC) guidelines for infection
control emphasize the importance of traffic patterns in the surgical suite, as well as
limiting the number of personnel involved in the procedure. Other national organizations
such as the Association of Operating Room Nurses (AORN) have made similar recommendations
that personnel traffic thru the operating room should be limited during surgical procedures.
Although these recommendations appear logical, they create significant performance pressure
for the operating room personnel, because it limits their abilities to do carry out the
duties during surgery by limiting their mobility in-and-out of the operating rooms. These
restrictions are especially difficult to implement for teaching institutions like the Barrow
Neurological Institute (BNI) that attract international observers who travel from other
countries, in order to stand inside of our operating rooms so they can watch and learn from
our neurosurgeons. Therefore, prior to instituting any restrictions on personnel movement
thru the operating rooms, the investigators feel it is imperative that class I data be
generated, in order to either prove or disprove that the level of personnel traffic in the
operating room correlates with infection rates.

In order to generate class 1 data, the investigators propose that a prospective, randomized
trial, hereafter referred to as the BRITE Trial, be conducted at the Barrow Neurological
Institute (BNI) at St Joseph's Hospital & Medical Center (SJHMC), Phoenix, Arizona. The
BRITE Trial will enroll all eligible patients undergoing a surgical procedure within the BNI
Operating Rooms for a period of one year, starting on January 1, 2013. The BNI Operating
Rooms contain 11 operating rooms where surgeries are conducted on a daily basis. The
investigators plan to divide the 11 BNI operating rooms into 2 different groups: Group A and
Group B. Group A will be operating rooms #1 thru #5. Group B will be operating rooms #6 thru
#11. Investigators plan to randomize both Group A and Group B to either "Normal O.R.
Traffic" or "Low O.R. Traffic" protocols. The randomization will occur in a dichotomous
fashion so Group A and Group B are never simultaneously randomized to the same O.R. Traffic
protocol. The randomization will occur at 6 a.m. on the Monday morning of each new week, and
the randomization designation will last for 7 consecutive days. Randomization will occur
thru a standard randomization computer program (www.random.org) and weekly designations will
be placed within sealed envelopes. The sealed envelope for each week will be opened at 6
a.m. on the Monday morning of that week. The group of operating rooms that is designated as
being under the "Low O.R. Traffic" protocol will have signs on the inside and outside of all
doors connected to these operating rooms. The "Low O.R. Traffic" protocol group will also be
required to adhere to a new set of rules and regulations. The group of operating rooms that
is designated as being under "Normal O.R. Traffic" protocol will have no signs on their
doors and they will follow the normal standards for O.R. personnel traffic, per routine.

Data reflecting personnel movement will be collected via a proprietary "personnel counting
system" (Traf-Sys, Pittsburgh, PA). The "personnel counting system" operates via infrared
beams mounted on the outside of every operating room door. When a person walks thru the
operating room door, the infrared beam is broken and the system records the movement of a
single person. These data will be tracked 24 hours a day, 7 days a week for a 365 day
period. An interim analysis will be conducted at 6 months. Primary outcome will be return to
the BNI operating room for wound washout within 12 months. Secondary outcome will be return
to BNI operating room for any reason. Our goal for the BRITE Trial is 2-fold. First, the
investigators want to determine whether or not instituting a Low O.R. Traffic protocol
actually leads to decreased O.R. personnel traffic thru the operating rooms. Second, the
investigators want to determine whether or not increased levels of O.R. personnel traffic
thru the operating rooms leads to increased rates of SSI's.

Inclusion Criteria:

- Subject undergoing a surgical procedure that will disrupt the epithelial lining of
the subject's body.

- The subject's procedure must occur within 1 of the 11 BNI Operating Rooms

Exclusion Criteria:

- Subjects undergoing procedures within the BNI Operating Rooms that do not disrupt the
epithelial lining of the subject's body

- Subjects undergoing surgical procedures outside of the BNI Operating Rooms

- Pregnant women

- Prison inmates