Pressure Injury Clinical Trial
— MORGENOfficial title:
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 Indicated Chronic Wound Types.
NCT number | NCT05632250 |
Other study ID # | WC-22-427 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 10, 2023 |
Est. completion date | March 13, 2024 |
Verified date | April 2024 |
Source | ConvaTec Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 95 |
Est. completion date | March 13, 2024 |
Est. primary completion date | March 13, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Foot and Ankle Specialists of the Mid-Atlantic | Hagerstown | Maryland |
United States | Hope Vascularity & Podiatry, PLLC | Houston | Texas |
United States | NYU Langone Health | Mineola | New York |
United States | Foot and Ankle Specialsts of the Mid-Atlantic | Raleigh | North Carolina |
United States | ProMedica Toledo Hospital | Toledo | Ohio |
Lead Sponsor | Collaborator |
---|---|
ConvaTec Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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