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)

April 27, 2024 updated by: ConvaTec Inc.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02218
        • Boston Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: ConvaFoam dressings
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
Device: ConvaFoam
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
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
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ConvaTec Inc.

Investigators

  • Study Chair: Kerem Ozer, MD, Medical Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 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

Other Study ID Numbers

  • WC-22-440

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe