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TurnCare: A Novel Approach to Pressure Injury Treatment and Prevention for Mobility-Impaired Patients

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Kim Orumchian, CEO and Dr. Rafael Squitieri, Co-Founder & CTO Pressure injuries (PIs) are a common and globally occurring health problem, characterized by localized damage to skin or underlying tissue, typically over a bony prominence. PIs are caused by prolonged, repetitive or sustained pressure, which leads to vascular compression and subsequent circulatory compromise. The commonly resulting ischemia and reperfusion injuries can have profound results both locally and systemically. PIs can be a debilitating complication resulting in significant pain, decreased quality of life for patients and families, and increased mortality and healthcare costs. PIs are particularly common in patients who are mobility impaired, and often require complex and costly care interventions such as negative pressure wound therapy (NPWT). In addition, PIs often result in expensive secondary complications such as infection, treatment of which can further increase length of hospital stay. It is estimated that in the U.S., PIs affect 2.5 million people and cost the healthcare system between $9 billion and $11 billion annually, as per Agency for Healthcare Research and Quality. Roughly 60,000 patients die each year as a direct result of pressure injuries.

"Our system can be beneficial in the healing of full-thickness PIs and can minimize the need for additional, costly wound management therapies"

Dr. Rafael Squitieri—Chief of Cardiothoracic Surgery at St. Vincent’s Medical Center in Bridgeport, CT—was concerned that patients continued to develop PIs further complicating their health, despite the expertise of clinical facilities and staff, the use of evidence-based prevention techniques such as alternating pressure beds, turning schedules, and risk assessment scores. Dr. Squitieri wondered why existing methods were not more effective in preventing PI development and avoiding further escalation of existing PIs. In 2011, he co-founded TurnCare, a medical-device company dedicated to addressing the problem.

Using his expert knowledge of the circulatory system, Dr. Squitieri understood that mitigating the underlying cause of PI—ischemia and reperfusion injury—required a solution that prevented the vasculature from becoming compressed. Existing pressure redistribution technologies are not designed to achieve this, because to support a patient over an extended period of time without compressing the vasculature requires an understanding of where and how much pressure is being applied to specific parts of the anatomy at any point in time. The part of the anatomy where patients experience the bulk of this problem is the sacral region, where pressure accumulates for those sitting or lying for extended periods. To solve this problem, Dr. Squitieri and his interdisciplinary team at TurnCare developed the Guardian System, a non-invasive inflatable surface designed to support patients without compromising circulation in the sacral region. Through Guardian’s patented geometry and anatomical awareness features, the system continuously modifies pressure in narrow, anatomically aligned air chambers using a sophisticated perpetual non-repeating algorithm. The Guardian System avoids applying too much or too repetitive pressure over the bony prominences, where the vasculature is most vulnerable, while still effectively and comfortably supporting the patient’s sacral region.

The TurnCare Guardian System reduces the chances of sustained vascular compression, prevents the occurrence of a compromised circulation, and protects against local skin injury and cell death

The Guardian can be utilized on multiple support surfaces such as beds, procedure tables, chairs, and wheelchairs, which is critical to providing continuous effective therapy from admission to discharge.

“The TurnCare Guardian System is an exciting new capability for clinicians determined to more effectively protect and treat their vulnerable patient populations,” says TurnCare CEO and co-founder Kim Orumchian.

The Guardian System has been shown to prevent and treat PIs more effectively than the current care protocols, reduce pain and discomfort, and reduce length of stay for specific patients such as those with stroke and/or acute kidney injury. In a randomized, controlled trial of 399 high-risk patients, the Guardian System showed a statistically significant 81% reduction in hospital-acquired PIs (HAPIs) in those patients who received Guardian therapy when compared to patients who were on alternating pressure beds.

Providing Care to Unstable ICU Patients

In clinical use, the Guardian System has shown efficacy in accelerating healing time and preventing PIs in high risk patients. In particular, TurnCare has been effective for critical care patients, more than 15 percent of whom are likely to develop PIs. Patients in critical care are at high risk for PIs because of characteristics such as sedation, altered consciousness, impaired mobility, treatment with mechanical ventilation, vaso-active medications, and unstable hemodynamic status. Critical care patients often have requirements based on pulmonary and/or physical rehabilitation status, ventilator weaning, overall respiratory status, and level of progressive mobility. In current practice, patients with more serious PIs, such as Deep Tissue Injuries and stage 3 or 4 PIs, are typically treated with air-fluidized therapy, a therapy that can be physically prohibitive to patients, that can slow their physical and pulmonary rehabilitation, and is difficult to manage and integrate into daily clinical routines. In contrast, the Guardian System is simple to use and integrate on any hospital surface, thereby better supporting the overall rehabilitation of the patient while providing effective PI therapy. “Guardian facilitates clinical workflows while at the same time helping clinicians to enhance health outcomes,” Orumchian states. The Guardian System is an effective PI therapy for critically ill patients with higher clinical ease of use and flexibility at a lower cost than the current alternatives.

This translates to better health outcomes with lower direct and indirect costs related to PI prevention and treatment.

Patient Case Studies

A 64-year old male patient developed a Stage IV sacral region PI in a skilled long-term care nursing facility after sustaining an incomplete level 4 cervical spinal cord injury with subsequent paraplegia. The PI was initially treated with sharp surgical debridement and NPWT. The Guardian System was introduced after 132 days with the wound measuring 2.0 x 1.3 x 0.6 cm. After 118 days of Guardian therapy, the Stage IV PI completely healed without any complications. The Guardian System also helped reduce associated pain and mobility impairment the patient had been experiencing. Summarizing the effectiveness of the Guardian System, Orumchian says, “Our system can be beneficial in the healing of full-thickness PIs and can minimize the need for additional, costly wound management therapies.”

In another case a stroke patient developed a Stage III PI in home hospice care. Use of traditional air mattresses to alleviate the pressure did not aid wound healing, and the required frequent physical handling was particularly distressing and painful to the patient, resulting in restlessness, increased pain and discomfort, and frequent attempts to climb out of bed. The Guardian System treatment had a profound positive impact on the patient almost immediately after being introduced. The Stage III PI completely healed within two months, provided significant pain reduction, and allowed weaning off oxygen therapy and a drastic reduction in medicine regime. The patient experienced increased alertness, improved sleep patterns, decreased distress, and was able to spend valuable quality time with his family during the last months of his life.

The Future

With the second generation of the TurnCare Guardian System launching in the fall of 2019, the company is introducing new capabilities focused on helping hospitals to better manage their critical care populations to prevent and treat Pressure Injuries. “In our conversations with hospitals and hospital systems, we hear ICU unit managers and charge nurses asking for better tools to improve outcomes without compromising clinical workflow,” explains Orumchian. “Furthermore, these tools need to have compelling value, ideally costing less and having higher ROIs to make a compelling case to value analysis”.

The second-generation Guardian leverages 3 years of clinical experience and feedback to introduce important capabilities such as mobility with battery power, quiet operation with light alarms, sophisticated remote patient monitoring, and much simpler operation with integrated training. These and other capabilities serve to minimize clinical effort and maximize successful operation of the system.

“Our mission at TurnCare is to protect the mobility impaired patient. We measure our success by every individual person whose quality of life is improved, pain is decreased, and outlook brightened,” Orumchian adds.

- Alex D’souza
August 28, 2019