Pivotal Study of an Antimicrobial Wound Dressing to Treat Chronic Wounds

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:

1. What is the cost-savings of using NanoSALV?
2. Do care providers perceive NanoSALV to be better, worse or the same as the standard of care in terms of usability and efficiency?
3. Does NanoSALV increase autonomy and competence of wound self-management for care providers/patients?
4. Were patients more satisfied, less satisfied or just as satisfied with NanoSALV compared to the standard of Care?
5. 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.

Conditions

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

Interventions

DEVICE

NanoSALV Catalytic

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

Sponsors & Collaborators

• Alberta Health services

  collaborator OTHER

• NanoTess Inc.

  collaborator UNKNOWN

• Chester Ho, MD

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-06

Primary Completion

2023-05-26

Completion

2023-05-30

Countries

• Canada

Study Locations