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A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoamâ„¢ dressings in the management of indicated chronic wound types.
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoamâ„¢ Silicone, ConvaFoamâ„¢ Border and ConvaFoamâ„¢ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ConvaFoam dressings | Other | All participants wounds will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 12 weeks as part of their standard of care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ConvaFoam | Device | ConvaFoamâ„¢ Border, ConvaFoamâ„¢ Non-Adhesive, and ConvaFoamâ„¢ Silicone dressings are designed to provide a moist wound healing environment. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. Patient's wounds will be assessed and a dressing from the above will be applied as part of their normal standard of care. The wounds will be assessed on a weekly basis for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds. | This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use | Performance will be measured by documenting the progress of the wound through a weekly standard wound assessment where progression with be measured by changes to the wound healing status from deteriorating to static, static to improvement or improved to healed | 12 weeks |
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Inclusion Criteria:
Patients aged 18 years and over
Patients able and willing to provide informed consent
Patients with wounds with a duration of no less than 2 months and no more than 12 months
Patients must be willing to complete the QoL (quality of life) questionnaires via a valid email address
Patients with at least one, but no more than two of the same wound indications which would require dressing according to the stage of the wound:
Patients must be willing to attend visits as per schedule in protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerem Ozere, MD | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foot and Ankle Specialists of the Mid-Atlantic | Hagerstown | Maryland | 21742 | United States | ||
| NYU Langone Health |
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Post Market Clinical Follow Up Study
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| To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use | As part of the study schedule Health Care Professionals to complete a questionnaire at the end of study to assess: Ease of use Ease of removal ( Atraumatic) Wear time (meets recommended guidelines in IFU) | 12 weeks |
| To measure the performance of ConvaFoam dressings in the management of chronic wounds from a patient perspective when used in accordance with the instructions for use | As part of the study schedule patients will be asked to complete a quality of life questionnaire on their first and final visit to measure: Dressing comfort ( patient satisfied with dressing comfort and able to resume activities of daily living | 12 weeks |
| To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use | Any device related adverse events such as wound complications, maceration, blistering, breakdown of peri wound skin edges or changes to skin integrity will be documented and reported as per protocol | 12 weeks |
| To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use | Any device related adverse events such will be documented and reported as per protocol | 12 weeks |
| Mineola |
| New York |
| 11501 |
| United States |
| Foot and Ankle Specialsts of the Mid-Atlantic | Raleigh | North Carolina | 20006 | United States |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| Hope Vascularity & Podiatry, PLLC | Houston | Texas | 77504 | United States |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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