Comparative Prevention-effectiveness Trial of DabirAIR Overlay System

Pressure ulcers (PUs) are localized skin or underlying tissue injury resulting from pressure
or from pressure combined with shear or friction. In the United States, the annual treatment
cost of PUs has been estimated at $11 billion and the cost to manage a single-full thickness
PU is almost $70,000. According to Beckrich and Aronovitch, in the U.S., almost 25% of the
approximately 1.6 million PUs that develop in acute care settings are acquired
intra-operatively during surgeries that last more than three hours. The average estimated
cost of treatment for the PUs in surgical patients is $750 million - $1.5 billion per year.

Surgical patients are at high risk for developing pressure ulcers due to the presence of many
risk factors that are specific to intra-operative environment. Intra-operative factors that
contribute to the development of pressure ulcers include patient weight, age, type of
surgery, time on operating table longer than 2.5 hrs, anesthetic agents, extra-corporeal
circulation, use of heating blanket and presence of vascular diseases.

The DabirAIR overlay system (DOS) is a semi-disposable, multi-patient use, alternating
pressure (AP) overlay for surgical and medsurg bed applications. The system was developed as
a new and innovative tool for surgeons and perioperative professionals alike to help reduce
the risks of deep tissue injury and hospital-acquired pressure ulcers resulting from long
surgical procedures in the OR.

Henry Ford Health System will evaluate the DabirAIR overlay system (DOS) for its
effectiveness in preventing hospital acquired pressure ulcer (HAPU) in the peri-operative
setting. The evaluation will be done in patients scheduled for neurosurgical procedures
(surgical procedures typically last longer than 3 hours). The primary objective of the study
is to compare the prevention-effectiveness (incidence rate of HAPU) between DOS (treatment
group) vs facility specific standard of care pressure-relieving device(s) (control group)
peri-operatively to discharge. About 400 patients in the treatment group will have their
neurosurgical procedures while lying on the DOS in the operating room. Half of the patients
from the treatment group will also be placed on the DOS in the post-op ICUs and recovery
units. Retrospective chart reviews will be performed for 400 patients who had neurosurgical
procedures while lying on the facility specific standard of care support surfaces in the
operating room and post-op ICUs.

It is hypothesized that the treatment group will have lower rate of HAPU compared to the
control group due to the pressure relief benefits offered by DOS. Prevention of HAPU will
result in improved quality of life and clinical outcomes and cost savings to the healthcare
facility.

Inclusion Criteria:

- Male and Female subjects

- 18 years of age and older

- Pre-planned neurosurgical procedure lasting more than 2.5 hours

Exclusion Criteria:

- Emergent cases without adequate documentation

- Patients with pre-existing pressure ulcer