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

NCT ID: NCT05902182

Last Updated: 2024-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-31
• Study Completion Date: 2024-12-31

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

Conditions

Skin Breakdown

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

ConvaFoam Dressings

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.

Group Type: EXPERIMENTAL

ConvaFoam

Intervention Type: DEVICE

ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings are designed to provide a moist wound healing environment and removing dead-space between the wound and dressing interface. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. In addition, the dressings are designed to protect fragile skin from moisture, shear, and friction damage. These will be used in line with the patients pressure injury mitigation protocol for a 2 week period, with daily inspections of the skin area.

Interventions

ConvaFoam

ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings are designed to provide a moist wound healing environment and removing dead-space between the wound and dressing interface. These dressings are designed to manage excess exudate levels which may further damage the wound bed and surrounding skin. In addition, the dressings are designed to protect fragile skin from moisture, shear, and friction damage. These will be used in line with the patients pressure injury mitigation protocol for a 2 week period, with daily inspections of the skin area.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ConvaTec Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

WC-22-426

Identifier Type: -

Identifier Source: org_study_id