Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown (DONNA)

Convatec

Status: Not yet enrolling

Conditions: Skin Breakdown

Treatments: Device: ConvaFoam

Study type: Interventional

Funder types: Industry

Identifiers

NCT05902182

WC-22-426

Details and patient eligibility

About

A prospective, multi centre, interventional, non-comparator, open label study to demonstrate the efficacy, safety, and performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive to protect against skin breakdown

Enrollment: 130 estimated 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/Personal Consultee/Nominated consultee/ Their nominated consultee
• Intact healthy skin
• Stage I pressure ulcer/injury
• Patients who are at risk of developing skin breakdown (injury), in any clinical setting, with at least one clinically vulnerable area (including but not limited to sacrum, heel, elbows, hips, ischial tuberosity and spine)
• Braden score of 12 or less

Exclusion criteria

• Patients with known allergies to any of the materials used in the dressing
• Subjects requiring any oxidising agents such as hydrogen peroxide or hypochlorite solutions
• Patients who are at high risk of unavoidable skin breakdown for example caused by a medical device (for example, under ventilation or faecal management systems)
• Patients with a wound of any aetiology on the area under investigation Patients who, in the opinion of the investigator, are considered unsuitable for any other reason
• Patients with a history of previous healed pressure ulcer/ injury in the area under investigation
• Patients who demonstrate a deterioration of skin from baseline skin assessment

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 1 patient group

ConvaFoam Dressings

Experimental group

Description:

All participants skin areas will be assessed and allocated a dressing based upon the investigator's clinical judgement. They will receive either ConvaFoam Border, Silicone or Non-Adhesive for up to 2 weeks as an addition to their standard pressure injury prevention protocol.

Treatment:

Device: ConvaFoam