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A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds (MATILDA)

Primary Purpose

Surgical Wound, Trauma-related Wound

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ConvaFoam
Sponsored by
ConvaTec Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgical Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients aged 18 years and over Patients able and willing to provide informed consent Patients with Surgical wounds including incisional wounds including laparoscopic wounds and surgical wounds healing by secondary intention. Patients with Traumatic wounds 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 who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions. Patients, who in the opinion of the investigator, is considered unsuitable for any other reason Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    ConvaFoam dressings

    Arm Description

    Participants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks

    Outcomes

    Primary Outcome Measures

    Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
    The efficacy will be measured by the dressings ability to manage exudate as demonstrated by: Lack of strikethrough Maintenance or improvement of peri-wound skin

    Secondary Outcome Measures

    Demonstrate the performance of ConvaFoam™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
    Performance will be measured by: Wound healing as anticipated by primary or secondary intention Wear time Atraumatic removal Pain (pre application during application and on removal) Dressing comfort (patient satisfied with dressing comfort, able to resume activities of daily living) Ease of use Ease of removal Health Care Practitioner satisfaction
    Demonstrate the safety of, ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of the indicated acute wounds when used in accordance with the IFU.
    Safety will be measured by: Adverse reaction (including wound complications such as maceration, bleeding, blistering / protection of peri-wound edges / peri-wound skin integrity) Device Malfunctions

    Full Information

    First Posted
    November 9, 2022
    Last Updated
    December 1, 2022
    Sponsor
    ConvaTec Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05632276
    Brief Title
    A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
    Acronym
    MATILDA
    Official Title
    A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 31, 2023 (Anticipated)
    Primary Completion Date
    July 28, 2023 (Anticipated)
    Study Completion Date
    August 25, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    ConvaTec Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
    Detailed Description
    A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds for up to 4 weeks

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Wound, Trauma-related Wound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    A 4-week device intervention to demonstrate the efficacy, performance and safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of surgical and traumatic wounds
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ConvaFoam dressings
    Arm Type
    Other
    Arm Description
    Participants wounds will be assessed and will be allocated ConvaFoam Border, Silicone or Non-Adhesive dressing based upon the investigator's clinical judgment. participants will receive a dressing as part of a protocol of care for up to a period of 4 weeks
    Intervention Type
    Device
    Intervention Name(s)
    ConvaFoam
    Other Intervention Name(s)
    ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive
    Intervention Description
    ConvaFoam™ Border, ConvaFoam™ Non-Adhesive, and ConvaFoam™ Silicone dressings are designed to provide a moist wound healing environment. All participants will be assigned a dressing based upon clinical judgement for a maximum of 4 weeks with weekly assessments and dressing changes
    Primary Outcome Measure Information:
    Title
    Demonstrate the efficacy of ConvaFoam ™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
    Description
    The efficacy will be measured by the dressings ability to manage exudate as demonstrated by: Lack of strikethrough Maintenance or improvement of peri-wound skin
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Demonstrate the performance of ConvaFoam™ Border, ConvaFoam™ Non-Adhesive and ConvaFoam™ Silicone to manage the indicated acute wounds when used in accordance with the IFU
    Description
    Performance will be measured by: Wound healing as anticipated by primary or secondary intention Wear time Atraumatic removal Pain (pre application during application and on removal) Dressing comfort (patient satisfied with dressing comfort, able to resume activities of daily living) Ease of use Ease of removal Health Care Practitioner satisfaction
    Time Frame
    4 weeks
    Title
    Demonstrate the safety of, ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive dressings in the management of the indicated acute wounds when used in accordance with the IFU.
    Description
    Safety will be measured by: Adverse reaction (including wound complications such as maceration, bleeding, blistering / protection of peri-wound edges / peri-wound skin integrity) Device Malfunctions
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged 18 years and over Patients able and willing to provide informed consent Patients with Surgical wounds including incisional wounds including laparoscopic wounds and surgical wounds healing by secondary intention. Patients with Traumatic wounds 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 who require any oxidising agents such as hydrogen peroxide or hypochlorite solutions. Patients, who in the opinion of the investigator, is considered unsuitable for any other reason Patients with wounds showing signs of infection on presentation or not resolving with the use of antibiotics
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alisha Oropallo, MD
    Phone
    001 516 233-3780
    Email
    aoropallo@northwell.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sally Kaplan
    Phone
    001 516 233-3780
    Email
    skaplan2@northwell.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kerem Ozer, MD
    Organizational Affiliation
    Medical Director
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Study to Demonstrate the Efficacy, Performance and Safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-Adhesive Dressings in the Management of Surgical and Traumatic Wounds

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