Chronic Ulcer of Leg or Foot, Pressure Injury
Conditions
Brief summary
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ dressings in the management of indicated chronic wound types.
Detailed description
A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of Chronic leg ulcers (including diabetic foot ulcers) and Pressure Injuries (Grade II and above)
Interventions
DEVICEConvaFoam
ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ 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.
Sponsors
ConvaTec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Post Market Clinical Follow Up Study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Chronic ulcers (Venous, arterial, mixed aetiology or diabetic foot ulcers) * Pressure Injury Stage II or greater * Patients must be willing to attend visits as per schedule in protocol
Exclusion criteria
* Patients with known allergies to any of the materials used in the dressing * Patients with known malignant wounds * Patients requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions * Patients, who in the opinion of the Investigator, are considered as unsuitable for any other reason * Patients with chronic conditions such as autoimmune disorders in an acute flare phase, which in the opinion of the investigator would directly impact wound healing, use of immunosuppressant medications may be allowed if they have been on a stable dose and regimen over the past three months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To measure efficacy of ConvaFoam dressings in the exudate management of chronic wounds. | 12 weeks | This will be measured by: Lack of strike through Loss of edge seal/adherence, Dressing leakage/seepage Dislodgement Need for dressing change |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use | 12 weeks | 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 |
| To measure the performance of ConvaFoam dressings from a care health Care Practitioners Practitioners Perspective when used in accordance with the instructions for use | 12 weeks | 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) |
| 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 | 12 weeks | 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 |
| To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use | 12 weeks | 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 |
Countries
United States
Outcome results
None listed