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Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds

Primary Purpose

Pressure Injury, Venous Leg Ulcer, Pressure Injury Stage 2

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
NanoSALV Catalytic
Sponsored by
Chester Ho, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pressure Injury focused on measuring pressure injury, chronic wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

No Intervention

Experimental

Arm Label

Control Period

Intervention Period

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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

Secondary Outcome Measures

Wound percent area change
Measured by: photographs of the wound using Aranz Silhouette Star 3D camera followed by wound area tracing and area analysis using Aranz Silhouette Star software.
Wound percent volume change
Measured by: photographs of the wound using Aranz Silhouette Star 3D camera followed by wound area tracing and volume analysis using Aranz Silhouette Star software.
Adverse events
Measured by: the number of confirmed adverse events documented.
Patient preference
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: Patient's choice of continuing with SOC or NanoSALV after study completion
Patient satisfaction - ease of use
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing ease of use
Patient satisfaction - comfort
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing comfort of wound dressing
Patient satisfaction - overall satisfaction
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing overall satisfaction with wound dressing

Full Information

First Posted
November 2, 2022
Last Updated
January 31, 2023
Sponsor
Chester Ho, MD
Collaborators
Alberta Health services, NanoTess Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05619237
Brief Title
Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds
Official Title
Act to Improve Chronic Wounds in Alberta: Pivotal Study on the Use of NanoSALV Antimicrobial Wound Dressing to Treat Chronic Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
April 7, 2023 (Anticipated)
Study Completion Date
April 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Chester Ho, MD
Collaborators
Alberta Health services, NanoTess Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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 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.
Detailed Description
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. Antimicrobial efficacy in-vitro testing of NanoKARE technology ranged from 0.5-6% for minimum inhibitory concentration (MIC) and 0.5-8% minimum bactericidal concentration (MBC) for all microorganisms tested. MIC/MBC testing was performed by JMI Laboratories. Biofilm in-vitro testing showed the technology was effective at eliminating all resistant biofilms tested and effectively prevented the formation of all biofilm strains. SARS-CoV-2 in-vitro surface testing also showed 99.9% reduction in viral strains after 30s of exposure and lasted up to 7 days after a single surface application. These tests were fully funded by the Canadian Department of Defense. OBJECTIVE: Objective: To assess the implementation feasibility and impact that a potential innovative solution NanoSalv to manage severe chronic wounds and pressure injuries may bring to the patient, provider and health system. METHODS: Patients with diabetic foot ulcers, venous leg ulcers and stage II to IV pressure injuries will be recruited. Each patient will receive four weeks of the standard of care and four weeks of the intervention. Weekly wound assessments will be done and wound images will be captured by a 3D medical camera that digitally takes measurements. Patients will be shown their wound images to show their progress of wound healing. To explore the perspectives on the current state of chronic wound management, review of care plan protocols, policies and procedures, Likert scales, and semi-structured interviews and observations will be done with care providers/patients and healthcare professionals from the different sites during the control period. To evaluate the perceptions on the usability of and experience with the intervention, semi-structured interviews and observations, and Likert scales will be done with the previously mentioned users of the intervention in the intervention period throughout the project implementation. The data collected will be analyzed using journey mapping, comparative task analysis, thematic analysis, and workflow analysis. Sample Size: The sample size was determined based in part on the feasibility of recruiting patients in the given timeline and the project personnel provided. A sample size of 95 patients with 10 weeks to recruit would average recruiting 8-9 patients per week. For the qualitative methods involving semi-structured interviews on current perspectives of standard care, interviews on perceptions, and usability of the intervention, 9-20 participants will be recruited to participate over the duration of the study period. The sequence and duration of all trial periods is as follows: Initiation: Potential participants will be identified by healthcare providers Research Staff will screen for eligibility with the Principal Investigator/Co-Investigator or the patient's attending physician and will consent eligible patients Required data will be collected about the patient and the wound at enrollment to provide a baseline measure on Day 0: Patient demographics (age, sex, type of wound), Charlson Comorbidities, wound measurements area and volume and photographs (using a 3D wound camera), and wound assessments (e.g., Bates-Jensen Wound Assessment Tool (BWAT), infection, pain) The wound will be debrided and cleaned as required by wound care Control Period: The patient will receive standard of care treatment for 4 weeks with dressing changes as per the standard care pathway. Wound measurements, images and assessments will be done every 7 days for weekly data collection Data collected on Day 7, 14, 21: wound area, volume, assessments and photographs (e.g., BWAT, infection, pain), dressing and standard of care (SOC) compliance On day 28 all patient wounds will be evaluated for the inclusion criteria: percentage area reduction of the wound ≤ 50%. Data collected on Day 28: wound area, volume assessments and photographs (e.g., BWAT, infection, pain), dressing compliance, patient satisfaction Wound clinic staff, long-term care (LTC) staff and patient/family caregivers will be asked to participate in 1h semi-structured interviews Intervention Period: Day 29, patient will start using the NanoSALV intervention and dressing changes done every 48 - 72 hours as required. Patient and wound will be assessed every 7 days for weekly data collection Data collected on Day 35, 42 and 49: wound area and volume assessments and photographs (e.g., BWAT, infection, pain), dressing compliance Data collected on Day 56: wound area and volume assessments and photographs (e.g., BWAT, infection, pain), wound QoL-14 (Note for wound clinic patients this will be done at the clinic), dressing compliance, patient satisfaction Wound clinic staff, LTC staff and patient/family caregivers will be asked to participate in 1h semi-structured interviews

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Participants and researchers will be aware of the phases of the study.
Allocation
Non-Randomized
Enrollment
95 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Period
Arm Type
No Intervention
Arm Description
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
Arm Title
Intervention Period
Arm Type
Experimental
Arm Description
Patients receive the intervention, NanoSALV wound dressing, in the consecutive four weeks following the control period
Intervention Type
Device
Intervention Name(s)
NanoSALV Catalytic
Intervention Description
NanoSALV Catalytic Antimicrobial Wound Dressing Gel is a Health Canada approved medical device for the management of Chronic Wounds.
Primary Outcome Measure Information:
Title
Soft Cost Savings
Description
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.
Time Frame
Through study completion over four months
Title
User Satisfaction
Description
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.
Time Frame
Through study completion over four months
Title
User Experience
Description
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.
Time Frame
Through study completion over four months
Title
Process Improvement
Description
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.
Time Frame
Through study completion over four months
Title
Quality Improvement
Description
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
Time Frame
Through study completion over four months
Secondary Outcome Measure Information:
Title
Wound percent area change
Description
Measured by: photographs of the wound using Aranz Silhouette Star 3D camera followed by wound area tracing and area analysis using Aranz Silhouette Star software.
Time Frame
Weekly assessments over 8 weeks
Title
Wound percent volume change
Description
Measured by: photographs of the wound using Aranz Silhouette Star 3D camera followed by wound area tracing and volume analysis using Aranz Silhouette Star software.
Time Frame
Weekly assessments over 8 weeks
Title
Adverse events
Description
Measured by: the number of confirmed adverse events documented.
Time Frame
Through study completion over four months
Title
Patient preference
Description
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: Patient's choice of continuing with SOC or NanoSALV after study completion
Time Frame
Weekly assessments over 8 weeks
Title
Patient satisfaction - ease of use
Description
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing ease of use
Time Frame
Change between Day 28 and Day 56 of study enrollment
Title
Patient satisfaction - comfort
Description
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing comfort of wound dressing
Time Frame
Change between Day 28 and Day 56 of study enrollment
Title
Patient satisfaction - overall satisfaction
Description
Evaluation of the patient's satisfaction with the use of NanoSALV in comparison to standard of care. Measured by: comparing patient satisfaction surveys post control and intervention periods using 10-point Likert scales assessing overall satisfaction with wound dressing
Time Frame
Change between Day 28 and Day 56 of study enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chester Ho, MD
Phone
7804927846
Email
chester.ho@ahs.ca
Facility Information:
Facility Name
Carewest Dr. Vernon Fanning Long-Term Care
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2E 6V7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Sheldon Chumir Wound Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2R 0X7
Country
Canada
Individual Site Status
Recruiting
Facility Name
Calgary Foot Care Nurses Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Glenrose Rehabilitation Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 0B7
Country
Canada
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds

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