Chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency), flaps, grafts and surgical incisions Not Applicable
Conditions
Interventions
The Healyx Labs NPWT suction unit provides suction at the gold standard level for Negative Pressure Wound Therapy (-125mmHg +/- 10%) from a built-in diaphragm pump powered by a DC motor. The pressure
Sponsors
Healyx Labs
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient is 18 years of age or older 2. Patient presents with an open wound 3. Patient is able to understand study requirements, is willing to undergo subject procedures, provide any required subject feedback, and provide informed consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patient who is pregnant or nursing 2. Patient with a non-survivable wound, life expectancy of 7 days or less 3. Patient’s wound is of malignant or vasculitis origin, or shows presence of necrotic tissue 4. Patient’s wound has active bleeding, exposed blood vessels or organs 5. Patient with wound-related comorbidities, including diabetic ketoacidosis, Hyperglycaemic Hyperosmolar Nonketotic Coma, vascular disease, or arthritis 6. Patient currently using medications that cause immune suppression 7. Patient with wound considered too difficult to seal based on location 8. Patient unable to understand study or provide informed consent to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ease of use measured by user reported rankings of device procedures at each dressing change: 1. Users (caregivers) are confident in setting up the device and creating successful suction. Device user completes a device assessment at each dressing change (twice per week) and at device removal measuring: 1.1. Overall satisfaction with a Likert scale 1.2. Usability compared to current wound therapies 2. Users are able to successfully remove the device during dressing changes. Device user completes a device assessment at each dressing change and at device removal measuring: 2.1. Overall satisfaction with a Likert scale 2.2. Usability compared to current wound therapies | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of device design evaluated by the incidence and intensity of device-related adverse events (AEs). Patient is interviewed and observed visually for device-related adverse events at treatment initiation and each dressing change 2. Healing progression at six weeks or conclusion of therapy, if earlier 3. Pain measured using a validated pain scale VAS recorded at 1x dressing change per week 4. Quality of life measured using questionnaire modified using the EuroQol Derived Single Index (EQ-DSI) recorded at 1x dressing change per week | — |
Countries
Nepal
Contacts
Public ContactCam Hutton
Outcome results
None listed