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.

NCT05632250 | Completed FDA Device

• 1 other identifier: WC-22-427
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Ulcer of Leg or Foot; Pressure Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To measure the performance of ConvaFoam dressings when used to manage chronic wound progression as per the instructions for use

  12 weeks

• 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

• 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

• To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

  12 weeks

• To measure the safety of Convafoam dressings when used to manage chronic wounds in accordance with the instructions for use

  12 weeks

Study Arms (1)

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

Device: ConvaFoam

Interventions

ConvaFoam DEVICE

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.

Also known as: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive

ConvaFoam dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Sites (5)

Foot and Ankle Specialists of the Mid-Atlantic

Hagerstown, Maryland, 21742, United States

Location

NYU Langone Health

Mineola, New York, 11501, United States

Location

Foot and Ankle Specialsts of the Mid-Atlantic

Raleigh, North Carolina, 20006, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Hope Vascularity & Podiatry, PLLC

Houston, Texas, 77504, United States

Location

MeSH Terms

Conditions

Pressure Ulcer

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kerem Ozere, MD

  Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Post Market Clinical Follow Up Study

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 30, 2022
• Study Start: April 10, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)