SBIR-STTR Award

Pressure Notification System To Prevent Pressure Ulcers
Award last edited on: 3/5/07

Sponsored Program
SBIR
Awarding Agency
NIH : NINDS
Total Award Amount
$827,125
Award Phase
2
Solicitation Topic Code
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Principal Investigator
John A Sabolich

Company Information

Sabolich Prosthetic & Research Center (AKA: Sabolich Research & Development~Scott Sabolich Prosthetics)

9400 North Broadway Suite 610
Oklahoma City, OK 73114
   (405) 841-6800
   sabolichcp@aol.com
   www.sabolich.com
Location: Single
Congr. District: 05
County: Oklahoma

Phase I

Contract Number: 1R43NR004663-01A1
Start Date: 00/00/00    Completed: 00/00/00
Phase I year
1998
Phase I Amount
$94,648
The development of a pressure notification system (PNS) is proposed for use as a practical adjunct in prevention of pressure ulcers. The overall health care costs for the treatment of pressure ulcers is estimated to be 3.5 billion dollars to 7 billion dollars annually. Despite the enormity of information available on the causes, prevention, and management of pressure ulcers, incidence rates remain unacceptably high. Factors contributing to this continuing public health problem include a diminished use of skilled nursing care due to a growing need to provide quality care in a cost-effective manner and a lengthened life span of seriously ill patients. The PNS alerts the patient and/or staff of prolonged localized pressure in areas predisposed to ulcer formation. This time-based monitoring strategy could augment existing schedule-based repositioning protocols by providing nursing staff with real-time status of their patients. The phase I effort will be divided into device development and a prospective pilot study. Understanding the relationship between exposure to pressure and healing rates of stage I or II pressure ulcers is the focus of this study and will provide valuable information about the ulcer healing process.Proposed Commercial Application:The long-term goal of this research is to develop a low-cost, technology-assisted prevention strategy to benefit bed and chair-bound patients predisposed to pressure ulcers in nursing homes, long-term care, and home care environments. A dramatic cost reduction to the general health care system could be realized with the successful development, commercialization, and implementation of the proposed system.

Thesaurus Terms:
biomechanics, biomedical equipment development, decubitus ulcer, disease /disorder prevention /control, monitoring device computer program /software, computer system design /evaluation clinical research, human subjectNATIONAL INSTITUTE OF NURSING RESEARCH

Phase II

Contract Number: 2R44NR004663-02A1
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2001
(last award dollars: 2002)
Phase II Amount
$732,477

Investigators seek to refine and test the efficacy of the Pressure Notification System (PNS) in this Phase II research. This system is a practical adjunct in the treatment of pressure ulcers in nursing homes, continuously monitoring the frequency and duration of localized pressure via a wireless sensor adhered to a wound dressing. Results of the Phase I prospective study suggest a relationship between frequency of weight shifts at the ulcer site and days to heal, Following device refinements, five nursing home facilities will participate in clinical research through an observational study and a clinical trial. The purpose of the observational study is to find notification parameter values to be used in the clinical trial by which to alert nursing staff of prolonged pressure on existing stage I and II ulcers. The efficacy of PNS intervention, as compared to conventional AHCPR two-hour turning schedule, will be evaluated in a controlled clinical trial. This technology could benefit patients by speeding healing and reducing related facility costs related to pressure ulcer care. PROPOSED COMMERCIAL APPLICATION: The long-term goal of this research is to develop a low-cost, technology-assisted prevention strategy to benefit bed and chair-bound patients predisposed to pressure ulcers in nursing homes, long-term care, and home care environments. A dramatic cost reduction to the genreal health care system could be realized with the successful development, commercialization, and implementation of the proposed system