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)

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: Surgical Wound; Trauma-related Wound
• Intervention / Treatment: Device: ConvaFoam

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

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

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

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; 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	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	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.	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

• Sponsor: ConvaTec Inc.
• Investigators: Study Chair: Kerem Ozer, MD, Medical director

Study record dates

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: Wounds and Injuries; Surgical Wound
• 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