Act to Improve Chronic Wounds in Alberta: Pivotal Study on the Use of NanoSALV Antimicrobial Wound Dressing to Treat Chronic Wounds

1. BACKGROUND:

Chronic wounds include, but are not limited, to diabetic foot ulcers (DFU), venous leg ulcers (VLU), and pressure ulcers. They are a challenge to wound care professionals and consume a great deal of healthcare resources. Chronic wounds are defined as wounds that fail to proceed through the normal phases of wound healing in an orderly and timely manner. Venous Leg Ulcer (VLU) is a recurrent chronic wound on the lower leg, and it is associated with venous obstruction or reflux, both of which also lead to poor venous flow and venous hypertension. A pressure injury (also known as a pressure ulcer) is defined by the National Pressure Injury Advisory Panel as a "localized damage to the skin and underlying soft tissue usually over a bony prominence or related to medical or other devices. The injury can present as intact skin or an open ulcer and may be painful". The development of a pressure injury is influenced by a variety of factors including age, mobility, nutrition, and other comorbid diseases/conditions. DFU is a frequent complication and hospitalization for individuals with diabetes mellitus (DM). As a result, these regions with limited sensitivity and chronic trauma can progress to an ulcer, potentially causing ischemia to the deep tissues, sometimes including the bone. These ulcerative tissues are highly susceptible to colonization and infection by multiple bacteria, and often result from the improper lack of care (debridement, antibacterials, etc). More severe DFUs may require surgical intervention and amputation, to prevent progression.

Pressure injuries have significant negative consequences for both patients and the health system. They compromise patient health outcomes, have been found to cause pain, hinder functional recovery and present a high risk for the development of serious infections. They have also been associated with an extended length of stay, sepsis and mortality. In a similar manner, VLU has significant social and economic burden to the patient and the healthcare system. Patient mobility, health-related quality of life, social roles, employment, and physical activity are negatively affected by this condition. Furthermore, besides the high quality of life and mortality burden related to DFU and amputations, health care costs and economic burden related to this issue are also high. Patients with DM complications, such as DFU, require frequent and significant medical care with expensive medical supplies and are often unable to work due to disease management issues and disability/mobility challenges.

Currently, the most effective practices for the treatment of chronic wounds involve: Cleansing (e.g.: with sterile water or saline), Debriding (e.g.: autolytic, mechanical, enzymatic etc.), managing bacterial balance (e.g.: with antibiotics) and managing moisture balance (e.g.: with draining). Dressings are recommended to promote healing (e.g.: to support drainage and provide tissue protection) and prevent infection (e.g.: antimicrobial products such as those impregnated with silver, honey or iodine). However, these products have drawbacks such as: not being able to conform to or sufficiently cover the wound, pain with wearing and/or removal, and only functioning to either promote healing OR treat the infection. An innovative solution should have features such as the ability to conform to the wound regardless of wound topography, be able to be worn for long periods, not be painful to wear, and have combined actions to simultaneously promote healing and be antimicrobial.

NanoSALV is a hydrogel wound dressing that contains NanoKARE technology, which is an advanced composite material that provides broad-spectrum antimicrobial and catalytic effects that reduce the thresholds needed to achieve optimal healing potential. NanoSALV wound dressing gel provides broad-spectrum antimicrobial effect against bacteria, fungi and viruses, and catalytic effects to achieve optimal healing potential. Has passed skin sensitization, irritation, acute systemic toxicity, and cytotoxicity during in-vitro testing. There are no known adverse events or reactions.