News August 2021

New Net Health Innovation Can Predict Risk of Amputations and Wound Healing Rates

Net Health recently announced the addition of two pioneering predictive analytic capabilities embedded in the workflow of the company’s widely used electronic health record (EHR) platform.

Offering artificial intelligence-based capabilities, the Net Health Wound Care software platform now includes the Risk of Amputation Indicator, developed to reduce the risk of amputations, and the Wound Healing Velocity Indicator, developed to predict wound healing rates, according to the company. Net Health says both capabilities will provide insights needed to develop optimal patient therapies, implement effective interventions, and plan treatment paths that will improve outcomes.
 
The company says the Risk of Amputation Indicator is a predictive analytics tool that informs clinicians of the likelihood that a wound could lead to an amputation by highlighting obstacles to recovery. The indicator is backed by a robust predictive model powered by decades of wound care insights. The Risk of Amputation Indicator considers approximately 175 parameters related to the patient and their wound(s). It provides clinicians with real-time predictions, giving them the knowledge needed to intervene and prevent unnecessary amputations.
 
The Wound Healing Velocity Indicator informs clinicians of the likelihood that a specific patient’s wound will heal within 4, 8, 12, or 16 weeks, notes the company. Unlike subjective assessments that vary significantly among clinicians or facilities, Net Health’s new indicator tool offers a real-time snapshot of a wound’s likelihood of healing based on an analysis of millions of wound care episodes and factors in hundreds of parameters that affect healing time.
 
The Net Health Wound Care application also offers insight into wound and patient-specific information that is helping or hurting a patient’s chance of healing. Pairing these predictive insights can help clinicians make more timely interventions to optimize a patient’s healing outcome, notes the company.
 
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SkinTE^® Meets Primary and Secondary Endpoints in Final Analysis from Diabetic Foot Ulcer Trial

PolarityTE, Inc. recently announced final data from a multi-center randomized controlled trial evaluating treatment of diabetic foot ulcers (DFU) with its investigational product SkinTE^® plus standard of care (SOC) vs SOC alone (NCT03881254). The trial met the primary endpoint of wound closure at 12 weeks and secondary endpoint of percent area reduction (PAR) assessed at 4, 6, 8, 10, and 12 weeks, according to the company. One hundred participants were evaluated across 13 sites with 50 participants receiving SkinTE plus SOC and 50 receiving SOC alone.

As part of the primary endpoint, PolarityTE says 70% (35/50) of participants receiving SkinTE plus SOC had wound closure at 12 weeks versus 34% (17/50) of participants receiving SOC alone. As part of the secondary endpoint, PAR assessed at 4, 6, 8, 10, and 12 weeks was significantly greater for the SkinTE plus SOC treatment group vs SOC alone. Wound size for the SkinTE plus SOC treatment group was 3.5 cm² versus 3.2 cm² for the SOC treatment group, notes a press release.

While this DFU study will not be considered to be a registrational trial as part of a Biologic License Application (BLA), PolarityTE says it incorporated data from the trial as part of its Investigational New Drug (IND) application to the FDA, which was submitted on July 23, 2021.

Additionally, PolarityTE announced a randomized controlled trial evaluating SkinTE versus SkinTE plus SOC in venous leg ulcers (VLUs) has been completed with a total of 29 enrolled participants, with results to be released in the second half of 2021.

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Integra Commits to Developing Greener Labs

Integra Biosciences has created a list of key steps that wound clinicians can take to help address environmental issues and reduce their overall resource consumption.

Worldwide, it is estimated that labs produce a staggering 5.5 billion kg of plastic waste per year, and use about four times more water and 10 times more electricity than office spaces of the same size. Although vital discoveries are pioneered in these labs, which has certainly been highlighted during the COVID-19 pandemic, the company notes this output is unsustainable.

Integra’s advice is largely summed up by the motto “reduce, reuse, recycle,” which addresses the sheer amount of waste generated each day in the lab. The company offers simple steps to help reduce waste—like keeping an inventory to know when to order items in bulk—or collaborating with other labs to share equipment and reagents, helping to avoid over-ordering of chemicals that may expire. Clinics might also be able to wash and reuse some conical tubes, reservoirs and plastic bottles, and Integra says simply knowing about local recycling programs enables you to set up corresponding bins to optimize waste disposal.

Integra also provides guidance on electricity and water consumption. As the company notes, simple steps like switching off devices and lights when they are not in use, using socket timers and closing the sash of the fume hood, and using ultra-low temperature freezers as sparingly as possible can all add up to a large overall reduction in electricity usage. For water savings, the company suggests equipping faucets with low-flow aerators, and only running dishwashers and autoclaves when full.

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Trial Underway for SSI Antimicrobial

Next Science Limited recently announced the beginning of a U.S. clinical trial for XPERIENCE™ No Rinse Antimicrobial Solution.

The trial, the TIFRAX (Tibial Fracture) Study, is a randomized, controlled, double-blinded, prospective study to evaluate the efficacy of XPERIENCE in helping decrease wound bioburden and surgical site infections (SSI), notes the company. It will also evaluate whether XPERIENCE can improve postoperative outcomes when used as adjunct treatment to standard of care in patients undergoing tibial fracture repair.

XPERIENCE is a no-rinse solution that Next Science says is designed to help prevent surgical site and postoperative infections by rinsing away debris and microorganisms. XPERIENCE breaks down biofilms.

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