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

Not Applicable

Not yet recruiting

• Conditions: Skin Breakdown
• Interventions: Device: ConvaFoam

• Registration Number: NCT05902182
• Lead Sponsor: ConvaTec Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-28
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-13
• Status Verified: 2023-08
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-05
• Study Start: 2024-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ConvaFoam Dressings	ConvaFoam	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.

Primary Outcome Measures

Name	Time	Method
To measure the efficacy of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect of skin against breakdown.	2 weeks	This will be measured by: • The incidence of skin breakdown

Secondary Outcome Measures

Name	Time	Method
To assess the performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.	2 weeks	This will be measured by reporting: The number of times the dressing has been lifted and reapplied before needing to be replaced compared to the instructions for use. The ability of the dressing to be reapplied to the skin following skin assessments as per the patients standard of care.
To assess the safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.	2 weeks	This will be measured via reporting all device related adverse events and device malfunctions, such as allergic reactions, bleeding, pain/discomfort in area of dressing, skin irritation, and reported as per protocol