Burns Clinical Trial
Official title:
A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.
The aim of the study is to evaluate participant reported quality of life, safety, and overall performance with ACTICOAT in a clinical setting.
ACTICOAT is a silver coated antimicrobial barrier wound dressing for the treatment of a
variety of wound types. It is widely used in routine clinical practice within the UK.
ACTICOAT is CE marked and will be used within the intended indications for use. The proposed
study is required for regulatory purposes.
Primary Objective: To evaluate change in health related quality of life, associated with
treatment. The primary outcome measure / endpoint will be change in EQ-5D 5L mean single
index utility scores from baseline to 3 weeks.
The study will also seek to gather and report relevant safety and performance data and
evaluate change, where applicable, for outcomes including: clinical signs and symptoms of
infection; wound length / width / depth; wound healing measures; tissue staining; pain,
adherence, and pain on application / removal; wear time; adverse events and device
deficiencies.
In total 25 participants will be recruited into the trial, comprising a minimum of 8
participants with a full or partial thickness burn and a minimum of 8 participants with a
full or partial thickness chronic wound. All participants will have their wound dressed using
ACTICOAT, and will be followed-up for 3 weeks.
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