Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds

The goal of this clinical trial is to assess the impact that the NanoSALV wound dressing can have on managing severe chronic wounds and feasibility for patients, providers, and health systems in different health care settings (community care, continuing care and in-patient care).The main questions it aims to answer are:What is the cost-savings of using NanoSALV?Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency?Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients?Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care?Does NanoSALV reduce healing time for chronic wounds compared to standard of care?The sequence and duration of the trial is as follows:Required data will be collected at enrollment to provide a baseline (Day 0) measure.The patient will receive standard of care treatment for four weeks with dressing changes as per the standard care pathway.In the following four weeks the patient will receive the NanoSALV dressing treatment and dressing changes done every 48 - 72 hours as required.Wound assessments will be done weekly with wound images captured by Aranz Medical's Silhouette Star 3D medical camera that digitally takes measurements.A patient satisfaction survey will be collected post-control and post-intervention periodsOne week after completing the study the patient/surrogate will be contacted or a survey link will be sent to them regarding adverse events and to see what wound dressing they continued to use.Semi-structured interviews and observations will be done with care providers/patients and healthcare professionals in the control period to explore the perspectives on the current state of chronic wound management, and in the intervention period to evaluate the perceptions on the usability of the intervention.

Inclusion Criteria:Adult patients, 18 years or overProvide informed consent or have a legal representative consent on their behalfAbility and willingness to adhere to the study requirements including weekly appointments and required site visits.Ability and willingness to comply with standard of care practices as per the type of woundSuspect chronic wound being treated with standard of care for at least 14 daysChronic wound inclusion criteria:Pressure InjuryStage II, III, or IVUlcer area post debridement between 2cm^2 and 50cm^2Diabetic Foot UlcerHave a diagnosis of diabetes mellitus type 1 or 2 or pre-diabeticUlcer area post debridement between 1cm^2 and 25cm^2Venous / Leg Ulcer- Ulcer area post debridement between 2cm^2 and 50cm^2Exclusion Criteria:Life expectancy less than 6 monthsNot responding to treatment for osteomyelitis and/or sepsisPresence of necrotic debris and/or gangrene post debridement is greater than 75% of wound surface areaFall within the contraindications of the intervention product (allergies to the any of the ingredients, pregnant or breast feeding)Currently participating in another study that would interfere with this study or would overburden the patient if enrolled in this studyPresence of a life-threatening disease with no current treatment plan