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

NCT05902182 | Unknown DMC

• 1 other identifier: WC-22-426
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• To measure the efficacy of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect of skin against breakdown.

  This will be measured by: • The incidence of skin breakdown

  2 weeks

Secondary Outcomes (2)

• To assess the safety of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.

  2 weeks

• To assess the performance of ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ non-adhesive dressings when used to protect skin against breakdown.

  2 weeks

Study Arms (1)

ConvaFoam Dressings

EXPERIMENTAL

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.

Device: ConvaFoam

Interventions

ConvaFoam 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.

ConvaFoam Dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ConvaTec Inc.: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: June 13, 2023
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 5, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share