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

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

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

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