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Completed

NCT Number: NCT05632276

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

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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Key information

Conditions

Surgical Wound Trauma-related Wound Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ConvaFoam

Device

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

Other names: ConvaFoam Silicone, ConvaFoam Border, ConvaFoam Non Adhesive

Primary outcomes

  1. 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

    Time frame: 4 weeks

    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 outcomes

  1. 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

    Time frame: 4 weeks

    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

  2. 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.

    Time frame: 4 weeks

    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

Sponsors and collaborators

Lead sponsor

ConvaTec Inc.

Industry

Registry information

Acronym: MATILDA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 30, 2022
Registry last updated
Apr 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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