Comparative Prevention-effectiveness Trial of DabirAIR Overlay System

Not Applicable

Completed

• Conditions: Pressure Ulcer

• Registration Number: NCT02565797
• Lead Sponsor: Dabir Surfaces Inc

Brief Summary

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 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2015-11
• Primary Completion: 2018-11
• Study Completion: 2019-12
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 392

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence rate of peri-operative hospital-acquired pressure ulcers (HAPU)	Peri-operative (up to 5 days from date of surgery)	Investigate the comparative prevention-effectiveness (incidence rate of hospital-acquired pressure ulcers (HAPU)) between DOS (treatment) vs facility specific pressure-relieving device(s) (control) peri-operatively to discharge. The primary outcome of interest in this study is development of a first acquired pressure ulcer in the hospital after surgery to discharge. Pressure ulcers identified within 5 days from date of surgery will be associated with the surgical procedure.

Secondary Outcome Measures

Name	Time	Method
Adverse events related to use of DabirAIR overlay	Peri-operative (up to 5 days from date of surgery)	Lack of adverse events related to use of DabirAIR overlay (during active use of overlay in OR and ICU/CCU). If any adverse events are reported, the causative factors for the adverse events will be analyzed and the adverse event will be grouped as study-device related or unrelated.
Cost-benefit of using DabirAIR	Peri-operative (up to 5 days from date of surgery)	Demonstrate the cost-benefit (return-on-investment) of DOS from the perspective of the hospital financial system. The main outcome measure is net financial costs or benefits per patient length of stay (LOS). Direct medical costs attributed to resource utilization, prevention devices and wound care will be estimated during the LOS in the hospital.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States