A Prospective, Non-comparative, Multicentre Study to Evaluate a Silver Coated Antimicrobial Barrier Wound Dressing (ACTICOAT™) in the Treatment of Burns and Chronic Wounds.

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Wound length(21 days)
• Wound depth(21 days)
• Amount of healthy tissue (% tissue types)(21 days)
• Ease of dressing removal(21 days)
• Serious adverse events(21 days)
• Clinical signs and symptoms of infection(21 days)
• Wound width(21 days)
• Condition of surrounding skin(21 days)
• Extent of tissue staining(21 days)
• Pain on dressing application(21 days)
• Non-serious adverse events(21 days)
• Reference wound healed (% re-epithelialized)(21 days)
• Pain on dressing removal(21 days)
• Ease of dressing application(21 days)
• Device deficiencies(21 days)