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

NCT05902182 — Not applicable, Unknown, 130 participants, ConvaTec Inc.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

A Prospective, Multi Centre, Interventional, Non-comparator, Open Label Post Market Clinical Follow up Study to Demonstrate the Efficacy and Safety of Convatec ConvaFoam™ Silicone, ConvaFoam™ Border and ConvaFoam™ Non-adhesive Dressings to Protect Against Skin Breakdown

Registry	NCT05902182, acronym DONNA
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, supportive care
Enrollment	130 (Estimated)
Sponsor	ConvaTec Inc. (Industry)
Conditions	Skin Breakdown
Interventions	ConvaFoam (Device)
Dates	start 2024-07-01 (estimated), primary completion 2024-12-01 (estimated), completion 2024-12-01 (estimated), first posted 2023-06-13, last updated 2024-04-05

-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

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+Arms and interventions

Arm	Type	Interventions	Description
ConvaFoam Dressings	Experimental	Device: 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.

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.

+Outcome measures

Primary outcomes

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 outcomes

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
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.

+Eligibility

Sex: All, ages: 18 Years to any

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