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)

Convatec

Status: Completed

Conditions: Surgical Wound; Trauma-related Wound

Treatments: Device: ConvaFoam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05632276

WC-22-440

Details and patient eligibility

About

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

Full 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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

ConvaFoam dressings

Other group

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

Treatment:

Device: ConvaFoam