Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds
Pressure Injury, Venous Leg Ulcer, Pressure Injury Stage 2
About this trial
This is an interventional treatment trial for Pressure Injury focused on measuring pressure injury, chronic wound
Eligibility Criteria
Inclusion Criteria: Adult patients, 18 years or over Provide informed consent or have a legal representative consent on their behalf Ability 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 wound Suspect chronic wound being treated with standard of care for at least 14 days Chronic wound inclusion criteria: Pressure Injury Stage II, III, or IV Ulcer area post debridement between 2cm^2 and 50cm^2 Diabetic Foot Ulcer Have a diagnosis of diabetes mellitus type 1 or 2 or pre-diabetic Ulcer area post debridement between 1cm^2 and 25cm^2 Venous / Leg Ulcer - Ulcer area post debridement between 2cm^2 and 50cm^2 Exclusion Criteria: Life expectancy less than 6 months Not responding to treatment for osteomyelitis and/or sepsis Presence of necrotic debris and/or gangrene post debridement is greater than 75% of wound surface area Fall 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 study Presence of a life-threatening disease with no current treatment plan
Sites / Locations
- Carewest Dr. Vernon Fanning Long-Term CareRecruiting
- Sheldon Chumir Wound ClinicRecruiting
- Calgary Foot Care Nurses ClinicRecruiting
- Glenrose Rehabilitation Centre
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control Period
Intervention Period
Patients receive the current standard of care for their chronic wound in the first four weeks of enrollment Standard of care (SOC) involves: Offloading of pressure as needed High compression bandaging, as needed Debridement, as needed Nutrition management, as needed SOC dressings, such as silver/iodine dressings, antibiotic ointment Management of infection Management of pain during debridement, as needed
Patients receive the intervention, NanoSALV wound dressing, in the consecutive four weeks following the control period