Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds

NCT05619237 | Completed DMC

• 1 other identifier: REB22-1394
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 4

Brief Summary

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:

• 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 periods
• One 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.

Conditions

Pressure Injury; Venous Leg Ulcer; Pressure Injury Stage 2; Pressure Injury Stage III; Diabetic Foot Ulcer; Pressure Injury Stage IV; Leg Ulcer

Keywords

pressure injury; chronic wound

Outcome Measures

Primary Outcomes (5)

• Soft Cost Savings

  Evaluation of the cost savings during the intervention period compared to the control period, by tracking indirect and direct costs including but not limited to, wound dressing costs, duration of treatment, frequency of dressing changes, in-clinic visit frequency, time and duration, in-home patient care, wound reduction rates, expenditure during control period and expenditure during intervention period, etc. This would be evaluated by a health economist and economic analysis support by the study sponsor.

  Through study completion over four months

• User Satisfaction

  Qualitative evaluation of the patient's and care provider's satisfaction with the Innovation in comparison to standard of care to inform future adoption decisions. Measured by: follow-up with User's desire to continue intervention over standard of care wound dressings as measured by the number of user's who sign up to continue with the intervention.

  Through study completion over four months

• User Experience

  Qualitative evaluation of the patient's and care provider's experience with the Innovation in comparison to standard of care to inform future adoption decisions. Measured by: Semi-structured interview themes will also be recorded to understand enablers and barriers to product use.

  Through study completion over four months

• Process Improvement

  Evaluation of workflow considerations with the Innovation in comparison to the standard of care. Measured by: documenting the frequency of dressing changes, and person who completes dressing changes to determine adoption and ability to change dressings outside of a healthcare setting. Task analysis will be conducted during the control and intervention to compare differences and similarities in tasks required to change dressing.

  Through study completion over four months

• Quality Improvement

  Evaluation of performance with the Innovation in comparison to the standard of care. Measured by: Subjective observations by human factors study team will be documented and follow-up interviews will be coded to reflect themes of enablers and barriers to standard of care vs intervention

  Through study completion over four months

Secondary Outcomes (7)

• Wound percent area change

  Weekly assessments over 8 weeks

• Wound percent volume change

  Weekly assessments over 8 weeks

• Adverse events

  Through study completion over four months

• Patient preference

  Weekly assessments over 8 weeks

• Patient satisfaction - ease of use

  Change between Day 28 and Day 56 of study enrollment

Study Arms (2)

Control Period

NO INTERVENTION

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

Intervention Period

EXPERIMENTAL

Patients receive the intervention, NanoSALV wound dressing, in the consecutive four weeks following the control period

Device: NanoSALV Catalytic

Interventions

NanoSALV Catalytic DEVICE

NanoSALV Catalytic Antimicrobial Wound Dressing Gel is a Health Canada approved medical device for the management of Chronic Wounds.

Intervention Period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chester Ho, MD: lead
• Alberta Health services: collaborator
• NanoTess Inc.: collaborator

Study Sites (4)

Carewest Dr. Vernon Fanning Long-Term Care

Calgary, Alberta, T2E 6V7, Canada

Location

Sheldon Chumir Wound Clinic

Calgary, Alberta, T2R 0X7, Canada

Location

Calgary Foot Care Nurses Clinic

Calgary, Alberta, T2V 4J2, Canada

Location

Glenrose Rehabilitation Centre

Edmonton, Alberta, T5G 0B7, Canada

Location

MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer; Diabetic Foot; Leg Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participants and researchers will be aware of the phases of the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Spinal Cord Injury Research Chair and

Model Details: Patients will receive the standard of care for the first 4 weeks. If the chronic wound has healed less than 50%, then the patient will receive the intervention for 4 weeks.

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 16, 2022
• Study Start: December 6, 2022
• Primary Completion: May 26, 2023
• Study Completion: May 30, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

CA (4)