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.

Pressure Injury Clinical Trial

— MORGEN  

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05632250
• Other study ID #: WC-22-427
• Status: Completed
• Phase: N/A
• Start date: April 10, 2023
• Est. completion date: March 13, 2024

Study information

• Verified date: April 2024
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Ulcer of Leg or Foot
• Crush Injuries
• Pressure Injury
• Pressure Ulcer

Intervention

Device:
• ConvaFoam
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Country where clinical trial is conducted

United States, 

Outcome

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