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. (MORGEN)

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.

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.

Study Overview

• Status: Completed
• Conditions: Pressure Injury; Chronic Ulcer of Leg or Foot
• Intervention / Treatment: Device: ConvaFoam

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)

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • Foot and Ankle Specialists of the Mid-Atlantic
  • New York
    • Mineola, New York, United States, 11501
      • NYU Langone Health
  • North Carolina
    • Raleigh, North Carolina, United States, 20006
      • Foot and Ankle Specialsts of the Mid-Atlantic
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital
  • Texas
    • Houston, Texas, United States, 77504
      • Hope Vascularity & Podiatry, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: ConvaFoam dressings; 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; 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.; Other Names: ConvaFoam Silicone; ConvaFoam Border; ConvaFoam Non Adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: ConvaTec Inc.
• Investigators: Study Director: Kerem Ozere, MD, Medical director

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): March 13, 2024
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Wounds and Injuries; Skin Ulcer; Crush Injuries; Pressure Ulcer
• Other Study ID Numbers: WC-22-427

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes